製品・サービス&サポート

製品に関する重要なお知らせ

自主回収/改修

全自動血液凝固測定装置 CAシリーズをご使用のお客様へのお知らせ(自主改修)

お客様各位
 

この度、弊社の全自動血液凝固測定装置CAシリーズにおいて、装置の設置時あるいは採用試薬変更時に、試薬にあわせてパラメータを設定しますが、一部の装置で誤ったパラメータを設定していたことが判明し、自主改修することにいたしました。
つきましては、本不具合に関して下記のとおり対応致しますので、ご協力のほど宜しくお願い致します。
 

医療機器改修の概要
(クラスⅡ)

1.一般的名称及び販売名
  一般的名称: 血液凝固分析装置
  販売名:

(1)全自動血液凝固測定装置 CA-500シリーズ
(2)全自動血液凝固測定装置 CA-600シリーズ
(3)全自動血液凝固測定装置 CA-1500
(4)全自動血液凝固測定装置 CA-6000
(5)全自動血液凝固測定装置 CA-8000
(6)全自動血液凝固測定装置 CA-7000

 

   

 

2.対象ロット、数量及び出荷時期
 

(1)全自動血液凝固測定装置 CA-500シリーズ
型式:CA-510

  数量: 835台
  製造番号:

11001,11002,11003,11004,11005,11006,11007,11008,11009,11010,
11011,11012,11013,11014,11015,11016,11017,11018,11019,11020,
11021,11022,11023,11024,11025,11026,11027,11028,11029,11030,
11031,11032,11033,11034,11035,11036,11037,11038,11039,11040,
11041,11042,11043,11044,11045,11046,11047,11048,11049,11050,
11051,11052,11053,11054,11055,11056,11057,11058,11059,11060,
11061,11062,11063,11064,11065,11066,11067,11068,11069,11070,
11071,11072,11073,11074,11075,11076,11077,11078,11079,11080,
11081,11082,11083,11084,11085,11086,11087,11088,11089,11090,
11092,11093,11094,11095,11096,11097,11098,11099,11100,11101,
11102,11103,11104,11105,11106,11107,11108,11109,11110,11111,
11112,11113,11114,11115,11116,11117,11118,11119,11120,11121,
11122,11123,11124,11125,11126,11127,11128,11129,11130,11131,
11132,11133,11134,11135,11136,11137,11138,11139,11140,11141,
11142,11143,11144,11145,11146,11147,11148,11149,11150,11151,
11152,11153,11154,11155,11156,11157,11158,11159,11160,11161,
11162,11163,11164,11165,11166,11167,11168,11169,11170,11171,
11172,11174,11175,11176,11177,11178,11179,11180,11181,11182,
11183,11184,11185,11186,11187,11188,11189,11190,11191,11192,
11193,11194,11195,11196,11197,11198,11199,11200,11201,11202,
11203,11204,11205,11207,11208,11209,11210,11211,11212,11213,
11214,11215,11216,11217,11218,11219,11220,11221,11222,11223,
11224,11225,11226,11227,11228,11229,11230,11231,11232,11233,
11234,11235,11236,11237,11238,11239,11240,11241,11242,11243,
11244,11245,11246,11247,11248,11250,11252,11253,11254,11255,
11256,11257,11258,11259,11260,11261,11262,11263,11264,11265,
11266,11267,11268,11269,11270,11271,11272,11273,11274,11275,
11276,11277,11278,11279,11280,11281,11282,11283,11284,11285,
11286,11287,11288,11289,11290,11291,11292,11293,11294,11295,
11296,11297,11300,11301,11302,11303,11304,11305,11306,11307,
11308,11309,11310,11311,11312,11313,11314,11315,11316,11317,
11318,11319,11320,11321,11322,11323,11324,11325,11326,11327,
11328,11329,11330,11331,11332,11333,11334,11335,11336,11337,
11338,11339,11340,11341,11342,11343,11344,11345,11346,11347,
11348,11349,11350,11351,11352,11353,11354,11355,11356,11357,
11358,11359,11360,11361,11362,11363,11364,11365,11366,11367,
11368,11369,11370,11371,11372,11373,11374,11375,11376,11377,
11378,11379,11380,11381,11382,11383,11384,11385,11386,11387,
11388,11389,11390,11391,11392,11393,11394,11395,11396,11397,
11398,11399,11400,11401,11402,11403,11404,11405,11406,11407,
11408,11409,11410,11411,11412,11413,11414,11415,11416,11417,
11418,11419,11420,11421,11422,11423,11424,11425,11426,11427,
11428,11429,11430,11431,11432,11433,11434,11435,11436,11437,
11438,11439,11440,11441,11442,11443,11444,11445,11446,11447,
11448,11449,11450,11451,11452,11453,11454,11455,11456,11457,
11458,11459,11460,11461,11462,11463,11464,11465,11466,11467,
11468,11469,11470,11471,11472,11473,11474,11475,11476,11477,
11478,11479,11480,11481,11482,11483,11484,11485,11486,11487,
11488,11489,11490,11491,11492,11493,11494,11495,11496,11497,
11498,11499,11500,11501,11502,11503,11504,11505,11506,11507,
11508,11509,11510,11511,11512,11513,11514,11515,11516,11517,
11518,11519,11520,11521,11522,11523,11524,11525,11526,11527,
11528,11529,11530,11531,11532,11533,11534,11535,11536,11537,
11538,11539,11540,11541,11542,11543,11544,11545,11546,11547,
11548,11549,11550,11551,11552,11553,11554,11555,11556,11557,
11558,11559,11560,11561,11562,11563,11564,11565,11566,11567,
11568,11569,11570,11571,11572,11573,11574,11575,11576,11577,
11578,11579,11580,11581,11582,11583,11584,11585,11586,11587,
11588,11589,11590,11591,11592,11593,11594,11595,11596,11597,
11598,11599,11600,11601,11602,11603,11604,11605,11606,11607,
11608,11609,11610,11611,11612,11613,11614,11615,11616,11617,
11618,11619,11620,11621,11622,11623,11624,11625,11626,11627,
11628,11629,11630,11631,11632,11633,11634,11635,11636,11637,
11638,11639,11640,11641,11642,11643,11644,11645,11646,11647,
11648,11649,11650,11652,11653,11654,11655,11656,11657,11658,
11659,11660,11661,11662,11663,11664,11665,11666,11667,11668,
11669,11670,11671,11672,11673,11674,11675,11676,11677,11678,
11679,11680,11681,11682,11683,11684,11685,11686,11687,11688,
11689,11690,11691,11692,11693,11694,11695,11696,11697,11698,
11699,11700,11701,11702,11703,11704,11705,11706,11707,11708,
11709,11710,11711,11712,11713,11714,11715,11716,11717,11718,
11719,11720,11721,11722,11723,11724,11725,11726,11727,11728,
11729,11730,11731,11732,11733,11734,11735,11736,11737,11738,
11739,11740,11741,11742,11743,11744,11745,11746,11747,11748,
11749,11750,11751,11752,11753,11754,11755,11756,11757,11758,
11759,11760,11761,11762,11763,11764,11765,11766,11767,11768,
11769,11770,11771,11772,11773,11774,11775,11776,11777,11778,
11779,11780,11781,11782,11783,11784,11785,11786,11787,11788,
11789,11790,11791,11792,11793,11794,11795,11796,11797,11798,
11799,11800,11801,11802,11803,11804,11805,11806,11807,11808,
11809,11810,11811,11812,11813,11814,11815,11816,11817,11818,
11819,11820,11821,11822,11823,11824,11825,11826,11827,11828,
11829,11830,11831,11832,11833,11834,11835,11836,11837,11838,
11839,11840,11841,11842,80100

  出荷時期: 平成9年7月17日~平成24年7月11日
   

 

 

型式:CA-530

  数量: 365台
  製造番号:

11001,11003,11005,11006,11007,11008,11009,11010,11011,11012,
11013,11014,11015,11016,11017,11018,11019,11020,11021,11022,
11023,11024,11026,11027,11028,11029,11030,11031,11032,11033,
11034,11035,11036,11037,11038,11039,11042,11043,11044,11045,
11046,11047,11048,11049,11050,11051,11052,11053,11054,11055,
11056,11057,11058,11059,11060,11061,11062,11063,11064,11065,
11066,11067,11068,11069,11070,11071,11072,11073,11074,11075,
11076,11077,11078,11079,11080,11081,11083,11084,11085,11086,
11087,11088,11089,11090,11091,11092,11093,11094,11095,11096,
11097,11098,11099,11100,11101,11102,11103,11104,11105,11106,
11107,11108,11109,11110,11111,11112,11113,11114,11115,11116,
11117,11118,11119,11120,11121,11122,11123,11124,11125,11126,
11127,11128,11129,11130,11131,11132,11133,11134,11135,11136,
11137,11138,11139,11140,11141,11144,11145,11146,11147,11148,
11149,11150,11151,11152,11153,11154,11155,11156,11157,11158,
11159,11160,11161,11162,11163,11164,11165,11166,11167,11168,
11169,11170,11171,11172,11173,11174,11175,11176,11177,11178,
11179,11180,11181,11182,11183,11184,11185,11186,11187,11188,
11189,11190,11191,11192,11193,11194,11195,11196,11197,11198,
11199,11200,11201,11202,11203,11204,11205,11206,11208,11209,
11210,11211,11212,11213,11214,11215,11216,11217,11218,11219,
11220,11221,11222,11223,11224,11225,11226,11227,11228,11229,
11233,11234,11235,11236,11237,11238,11239,11240,11241,11242,
11243,11244,11245,11246,11247,11248,11249,11250,11251,11252,
11253,11254,11255,11256,11257,11258,11259,11260,11261,11262,
11263,11264,11265,11266,11267,11268,11269,11270,11271,11272,
11273,11274,11275,11276,11277,11278,11279,11280,11281,11282,
11283,11284,11285,11286,11287,11288,11289,11290,11291,11292,
11293,11294,11295,11296,11297,11298,11299,11301,11302,11303,
11304,11305,11306,11307,11308,11309,11310,11311,11312,11313,
11314,11315,11316,11317,11318,11319,11320,11321,11322,11323,
11324,11325,11326,11327,11328,11329,11330,11331,11332,11333,
11334,11335,11336,11337,11338,11339,11340,11341,11342,11343,
11344,11345,11346,11347,11348,11349,11350,11351,11352,11353,
11354,11355,11356,11357,11358,11359,11360,11361,11362,11363,
11364,11365,11366,11367,11368,11369,11370,11371,11372,11373,
11374,11375,11376,11377,12976

  出荷時期: 平成9年9月24日~平成23年9月27日
   

 

 

型式:CA-550

  数量: 340台
  製造番号:

11001,11002,11003,11004,11005,11006,11007,11008,11009,11010,
11011,11012,11013,11014,11015,11016,11017,11018,11019,11020,
11021,11022,11023,11024,11025,11026,11027,11028,11029,11030,
11031,11032,11033,11034,11035,11036,11037,11038,11039,11040,
11041,11042,11043,11044,11045,11046,11047,11048,11049,11050,
11051,11052,11053,11054,11055,11056,11057,11058,11059,11060,
11061,11062,11063,11064,11065,11066,11067,11068,11069,11070,
11071,11072,11073,11074,11075,11076,11077,11078,11079,11080,
11081,11082,11083,11084,11085,11086,11087,11088,11089,11090,
11091,11092,11093,11094,11095,11096,11097,11098,11099,11100,
11101,11102,11103,11104,11105,11106,11107,11108,11109,11110,
11111,11112,11113,11114,11115,11116,11117,11119,11120,11121,
11122,11123,11124,11125,11126,11127,11128,11129,11130,11131,
11132,11133,11134,11135,11136,11137,11138,11139,11140,11141,
11142,11143,11144,11145,11146,11147,11148,11149,11150,11151,
11152,11153,11154,11155,11156,11157,11158,11159,11160,11161,
11162,11163,11164,11165,11167,11168,11169,11170,11171,11172,
11173,11174,11175,11176,11177,11178,11179,11180,11181,11182,
11183,11184,11185,11186,11187,11188,11189,11190,11191,11192,
11193,11194,11195,11196,11197,11198,11199,11200,11201,11202,
11203,11204,11205,11206,11207,11208,11209,11210,11211,11212,
11213,11214,11215,11216,11217,11218,11219,11223,11224,11225,
11226,11227,11228,11229,11230,11231,11232,11233,11234,11235,
11236,11237,11238,11239,11240,11241,11242,11243,11244,11245,
11246,11247,11248,11249,11250,11251,11252,11253,11254,11255,
11256,11257,11258,11259,11260,11261,11262,11263,11264,11265,
11266,11267,11268,11270,11271,11272,11274,11275,11276,11277,
11278,11279,11280,11281,11282,11283,11284,11285,11286,11287,
11289,11290,11291,11292,11293,11294,11295,11296,11297,11298,
11299,11300,11301,11302,11303,11304,11305,11306,11307,11308,
11309,11310,11311,11312,11313,11314,11315,11316,11317,11318,
11319,11320,11321,11322,11323,11324,11325,11326,11327,11328,
11329,11331,11332,11333,11334,11335,11336,11337,11338,11339,
11340,11341,11342,11344,11345,11346,11347,11348,11349,11352

  出荷時期: 平成13年4月1日~平成24年3月27日
   

 

 

(2)全自動血液凝固測定装置 CA-600シリーズ
型式:CA-620

  数量: 268台
  製造番号:

11003,11004,11005,11006,11007,11008,11009,11010,11011,11012,
11014,11016,11018,11019,11020,11021,11023,11025,11026,11027,
11028,11029,11035,11036,11037,11038,11039,11040,11041,11043,
11046,11053,11056,11065,11070,11071,11072,11073,11074,11075,
11076,11077,11078,11085,11086,11089,11090,11091,11096,11103,
11104,11121,11136,11139,11172,11173,11190,11191,11192,11194,
11210,11211,11212,11220,11237,11238,11245,11246,11249,11250,
11266,11267,11301,11304,11311,11312,11313,11314,11315,11316,
11344,11451,11457,11506,11507,11508,11509,11510,11511,11512,
11605,11607,11608,11616,11617,11624,11625,11626,11627,11628,
11631,11657,11658,11659,11660,11661,11662,11708,11709,11710,
11713,11714,11716,11717,11742,11743,11744,11758,11760,11761,
11762,11763,11764,11765,11766,11767,11781,11782,11783,11784,
11785,11819,11820,11821,11837,11878,11898,11899,11900,11907,
11908,11909,11993,11994,11995,11996,11997,11998,12010,12053,
12054,12090,12092,12101,12103,12104,12105,12110,12111,12112,
12114,12149,12150,12155,12165,12166,12180,12181,12216,12217,
12225,12239,12266,12270,12299,12373,12375,12376,12377,12380,
12396,12397,12398,12399,12400,12401,12447,12448,12481,12482,
12483,12542,12556,12610,12611,12612,12613,12630,12631,12632,
12633,12654,12779,12780,12781,12795,12796,12797,12798,12799,
12800,12849,12898,12899,12900,12901,12902,12903,12904,12905,
13054,13055,13056,13108,13109,21665,23133,23149,23150,23198,
23199,23223,23225,23226,23227,23228,23229,23275,23319,23320,
23399,23400,23401,23402,23439,23440,23447,23481,23482,23483,
23484,23485,23716,23732,23734,23735,23738,23812,23818,23840,
23841,23842,23843,23923,23924,23927,23928,23929

  出荷時期: 平成23年9月26日~令和元年7月8日
   

 

 

型式:CA-650

  数量: 465台
  製造番号:

11001,11002,11003,11004,11005,11006,11007,11008,11009,11010,
11011,11013,11014,11015,11016,11017,11018,11019,11021,11022,
11023,11024,11025,11026,11027,11028,11029,11030,11032,11033,
11034,11036,11038,11041,11042,11043,11044,11045,11046,11047,
11049,11050,11053,11054,11055,11056,11057,11059,11060,11062,
11063,11064,11066,11067,11069,11070,11071,11072,11073,11074,
11075,11076,11077,11078,11079,11080,11081,11082,11086,11087,
11088,11089,11090,11091,11092,11093,11094,11095,11096,11097,
11100,11101,11102,11103,11104,11105,11106,11107,11108,11109,
11110,11111,11112,11113,11114,11115,11116,11117,11118,11119,
11120,11121,11122,11123,11124,11125,11126,11127,11128,11129,
11130,11131,11132,11133,11134,11135,11136,11137,11138,11139,
11140,11141,11142,11143,11144,11145,11146,11147,11148,11149,
11150,11151,11152,11153,11154,11155,11156,11157,11158,11160,
11161,11162,11163,11164,11165,11166,11167,11168,11169,11170,
11171,11172,11173,11174,11175,11176,11177,11178,11179,11180,
11181,11182,11183,11184,11185,11186,11187,11188,11189,11190,
11191,11192,11193,11194,11195,11196,11197,11198,11199,11200,
11201,11202,11203,11204,11205,11206,11207,11208,11209,11210,
11211,11212,11213,11214,11215,11216,11217,11218,11219,11220,
11221,11222,11223,11224,11225,11226,11227,11228,11229,11235,
11236,11243,11244,11245,11246,11247,11248,11249,11250,11251,
11252,11253,11254,11255,11256,11257,11258,11259,11260,11261,
11262,11263,11264,11265,11266,11267,11268,11269,11270,11271,
11272,11273,11274,11275,11276,11277,11278,11279,11280,11281,
11282,11283,11284,11285,11286,11287,11288,11289,11290,11291,
11292,11293,11296,11297,11298,11299,11300,11301,11302,11303,
11304,11305,11306,11307,11308,11309,11310,11311,11312,11313,
11314,11315,11316,11317,11318,11319,11322,11326,11327,11328,
11329,11330,11331,11332,11333,11334,11335,11336,11337,11338,
11339,11340,11341,11342,11343,11344,11345,11348,11350,11351,
11352,11353,11354,11355,11356,11357,11358,11359,11360,11361,
11362,11364,11365,11366,11367,11368,11369,11370,11371,11373,
11374,11375,11376,11377,11378,11379,11380,11381,11382,11384,
11385,11386,11387,11388,11389,11390,11391,11392,11393,11394,
11395,11396,11397,11399,11400,11401,11402,11404,11405,11406,
11407,11414,11415,11416,11417,11418,11419,11420,11421,11422,
11423,11424,11425,11426,11427,11428,11429,11430,11431,11440,
11441,11442,11443,11444,11445,11446,11447,11452,11453,11454,
11455,11456,11457,11458,11459,11460,11461,11462,11483,11484,
11485,11486,11487,11488,21490,21491,21492,21493,21494,21495,
21496,21497,21498,21504,21505,21506,21507,21508,21509,21510,
21511,21512,21513,21518,21519,21528,21536,21537,21538,21539,
21540,21541,21542,21543,21544,21545,21546,21547,21548,21549,
21550,21551,21552,21553,21554,21556,21561,21562,21563,21564,
21565,21566,21567,21568,21569,21576,21577,21578,21579,21580,
21581,21583,21584,21585,21587

  出荷時期: 平成23年9月22日~令和元年6月27日
   

 

 

型式:CA-660

  数量: 1台
  製造番号:

12937

  出荷時期: 平成27年9月28日
   

 

 

(3)全自動血液凝固測定装置 CA-1500

  数量: 883台
  製造番号:

11001,11003,11004,11005,11006,11007,11008,11009,11010,11011,
11012,11013,11014,11015,11016,11018,11019,11020,11021,11022,
11023,11024,11025,11026,11027,11028,11028,11029,11030,11031,
11032,11033,11034,11035,11036,11037,11038,11039,11040,11041,
11042,11043,11044,11045,11046,11047,11048,11049,11050,11051,
11052,11053,11054,11055,11056,11057,11058,11059,11060,11061,
11062,11063,11064,11065,11066,11067,11068,11069,11070,11071,
11072,11073,11074,11075,11076,11077,11078,11079,11080,11081,
11082,11083,11084,11085,11086,11087,11088,11089,11090,11091,
11092,11093,11094,11095,11096,11097,11098,11099,11100,11101,
11102,11103,11104,11105,11106,11107,11108,11109,11110,11111,
11112,11113,11114,11115,11116,11117,11118,11119,11120,11121,
11122,11123,11124,11125,11126,11127,11128,11129,11130,11131,
11133,11134,11135,11137,11138,11139,11140,11141,11142,11143,
11144,11145,11146,11147,11148,11149,11150,11151,11152,11153,
11154,11155,11156,11157,11158,11159,11160,11161,11162,11163,
11164,11165,11166,11167,11168,11169,11170,11171,11172,11173,
11174,11175,11176,11177,11178,11179,11180,11181,11182,11183,
11184,11186,11187,11188,11189,11190,11191,11192,11193,11194,
11195,11196,11197,11198,11199,11200,11201,11202,11204,11205,
11206,11207,11208,11210,11211,11212,11213,11214,11215,11216,
11217,11218,11219,11220,11221,11222,11223,11224,11225,11226,
11227,11228,11229,11230,11231,11232,11233,11234,11235,11236,
11237,11238,11239,11240,11241,11242,11243,11244,11245,11246,
11247,11248,11249,11250,11251,11252,11253,11254,11255,11256,
11257,11258,11259,11261,11262,11263,11264,11266,11267,11269,
11270,11271,11272,11273,11274,11275,11276,11277,11278,11279,
11282,11283,11284,11285,11286,11287,11288,11289,11290,11291,
11292,11293,11294,11295,11296,11297,11298,11299,11301,11302,
11303,11304,11305,11306,11307,11308,11309,11310,11311,11312,
11313,11314,11315,11316,11317,11318,11319,11320,11321,11322,
11323,11324,11325,11325,11327,11328,11329,11330,11331,11332,
11333,11334,11335,11336,11337,11338,11339,11340,11341,11342,
11343,11344,11345,11346,11347,11348,11349,11350,11351,11352,
11353,11354,11355,11356,11357,11358,11359,11361,11362,11363,
11364,11365,11366,11367,11368,11369,11370,11371,11372,11373,
11374,11375,11376,11377,11378,11379,11380,11381,11382,11383,
11384,11385,11386,11387,11388,11389,11390,11391,11392,11393,
11394,11395,11396,11397,11398,11399,11400,11401,11402,11403,
11404,11405,11406,11407,11408,11409,11410,11411,11412,11413,
11414,11415,11416,11417,11418,11419,11420,11421,11422,11423,
11424,11425,11426,11427,11428,11429,11430,11431,11432,11433,
11434,11435,11436,11437,11438,11439,11440,11441,11442,11443,
11444,11445,11446,11447,11448,11449,11450,11451,11452,11453,
11454,11455,11456,11457,11458,11459,11460,11461,11462,11463,
11464,11465,11466,11467,11468,11469,11470,11471,11472,11474,
11475,11476,11477,11478,11479,11480,11481,11482,11483,11484,
11489,11491,11492,11493,11494,11495,11496,11497,11498,11499,
11500,11501,11502,11503,11504,11505,11506,11507,11508,11509,
11510,11511,11512,11513,11514,11515,11516,11517,11518,11519,
11520,11521,11522,11523,11524,11525,11526,11527,11528,11529,
11530,11531,11532,11533,11534,11535,11536,11537,11538,11539,
11540,11541,11542,11543,11544,11545,11546,11547,11548,11549,
11550,11551,11552,11553,11554,11555,11556,11557,11558,11559,
11560,11561,11562,11563,11564,11565,11566,11567,11568,11569,
11570,11571,11572,11573,11574,11575,11576,11577,11578,11579,
11580,11581,11582,11583,11584,11585,11586,11587,11588,11589,
11590,11591,11592,11593,11594,11595,11596,11597,11598,11599,
11600,11601,11602,11603,11604,11605,11606,11607,11608,11609,
11610,11611,11612,11613,11614,11615,11616,11617,11618,11619,
11620,11621,11622,11623,11624,11625,11626,11627,11628,11629,
11630,11631,11632,11633,11634,11635,11636,11637,11638,11639,
11640,11641,11642,11643,11644,11645,11646,11647,11648,11649,
11650,11651,11652,11653,11654,11655,11656,11657,11658,11659,
11660,11661,11662,11663,11664,11665,11666,11667,11668,11669,
11670,11671,11672,11673,11674,11675,11676,11677,11678,11679,
11680,11681,11682,11683,11684,11685,11686,11687,11688,11689,
11690,11691,11692,11693,11694,11695,11696,11697,11698,11699,
11700,11701,11702,11703,11704,11705,11707,11708,11709,11710,
11711,11712,11713,11714,11715,11716,11717,11718,11719,11720,
11721,11722,11723,11724,11726,11727,11728,11729,11730,11731,
11732,11733,11734,11735,11736,11737,11738,11739,11740,11741,
11742,11743,11744,11745,11746,11747,11748,11749,11750,11751,
11752,11753,11754,11755,11756,11757,11758,11759,11760,11761,
11762,11763,11764,11765,11766,11767,11768,11769,11770,11771,
11772,11773,11775,11776,11777,11778,11779,11780,11781,11782,
11783,11784,11785,11786,11787,11788,11789,11790,11791,11792,
11793,11794,11795,11796,11797,11798,11799,11800,11801,11802,
11803,11804,11805,11806,11807,11808,11809,11810,11811,11812,
11813,11814,11815,11816,11817,11819,11820,11821,11822,11823,
11825,11826,11827,11828,11830,11831,11832,11833,11834,11835,
11836,11837,11838,11839,11840,61841,61843,61844,61845,61846,
61847,61848,61849,61850,61851,61852,61853,61854,61855,61856,
61859,61861,61863,61864,61865,61866,61867,61868,61869,61870,
61871,61872,61874,61875,61877,61878,61879,61880,61881,61882,
61883,61884,61885,61886,61887,61888,61889,61890,61891,61892,
61893,61894,61895,61897,61898,61899,61900,61901,61902,61903,
61904,61905,61906,61907,61908,61909,61910,61911,61912,61913,
61914,61915,99001

  出荷時期: 平成10年3月31日~平成27年3月25日
   

 

 

(4)全自動血液凝固測定装置 CA-6000

  数量: 291台
  製造番号:

11001,11002,11004,11005,11006,11007,11008,11009,11011,11012,
11013,11014,11014,11015,11017,11018,11019,11021,11022,11023,
11024,11025,11026,11027,11028,11029,11030,11031,11032,11033,
11034,11035,11036,11037,11039,11040,11041,11042,11043,11045,
11046,11047,11048,11049,11050,11051,11052,11053,11054,11055,
11056,11057,11058,11059,11060,11062,11063,11064,11065,11066,
11067,11068,11069,11070,11071,11072,11073,11074,11075,11076,
11077,11078,11079,11080,11081,11082,11083,11084,11085,11086,
11087,11088,11089,11090,11091,11092,11093,11095,11096,11097,
11098,11099,11100,11101,11102,11103,11104,11105,11106,11107,
11108,11109,11110,11111,11112,11113,11114,11115,11116,11117,
11118,11119,11120,11121,11122,11123,11124,11125,11126,11127,
11128,11129,11130,11131,11132,11133,11134,11135,11137,11138,
11139,11140,11141,11142,11143,11144,11145,11148,11149,11151,
11152,11153,11154,11155,11156,11157,11158,11159,11160,11161,
11162,11163,11164,11165,11166,11167,11168,11169,11170,11171,
11172,11173,11174,11175,11176,11177,11178,11179,11180,11181,
11182,11183,11184,11185,11187,11188,11189,11190,11191,11192,
11193,11195,11196,11197,11198,11199,11200,11202,11203,11204,
11205,11206,11207,11208,11209,11210,11211,11212,11213,11214,
11215,11216,11217,11218,11219,11220,11221,11222,11223,11224,
11225,11226,11227,11228,11231,11232,11233,11234,11235,11236,
11237,11238,11239,11240,11241,11245,11246,11247,11248,11249,
11250,11251,11257,11258,11259,11260,11261,11262,11270,11271,
11272,11273,11274,11275,11276,11277,11278,11279,11280,11281,
11282,11283,11284,11285,11286,11287,11288,11290,11293,11294,
11295,11296,11297,11298,11299,11300,11301,11302,11303,11304,
11305,11306,11307,11308,11309,11310,11311,11312,11314,11315,
11316,11317,11318,11319,11320,11321,11323,11324,11325,80121,
80322

  出荷時期: 平成5年4月28日~平成18年12月22日
   

 

 

(5)全自動血液凝固測定装置 CA-8000

  数量: 16台
  製造番号:

11001,11013,11003,11004,11005,11006,11007,11009,11010,11011,
11012,11014,11016,11020,11023, 11024

  出荷時期: 平成22年9月25日~平成24年5月31日
   

 

 

(6)全自動血液凝固測定装置 CA-7000

  数量: 159台
  製造番号:

11002,11003,11004,11005,11006,11008,11009,11010,11011,11012,
11013,11014,11015,11016,11017,11019,11020,11021,11022,11023,
11024,11025,11026,11027,11028,11029,11030,11031,11032,11033,
11034,11035,11037,11038,11039,11040,11041,11042,11043,11045,
11046,11047,11048,11049,11050,11051,11052,11053,11056,11057,
11058,11059,11061,11062,11063,11063,11064,11065,11066,11067,
11068,11069,11070,11071,11072,11073,11074,11075,11076,11077,
11078,11079,11080,11081,11082,11083,11084,11085,11086,11087,
11088,11089,11090,11090,11091,11092,11093,11094,11095,11096,
11097,11098,11099,11100,11101,11102,11103,11104,11105,11106,
11107,11108,11109,11110,11111,11112,11114,11115,11116,11117,
11118,11119,11120,11121,11122,11123,11124,11125,11126,11127,
11128,11129,11130,11131,11132,11133,11134,11135,11136,11137,
11138,11139,11140,11141,11142,11143,11144,11145,11146,11147,
11148,11149,11150,11151,11152,11153,11154,11155,11157,11158,
11159,11160,11161,11162,11163,11164,11165,11173,81063

  出荷時期: 平成11年7月31日~平成23年10月5日
   

 

3.製造販売業者等
  製造販売業者の名称 : シスメックス株式会社
  製造販売業者の所在地: 兵庫県神戸市中央区脇浜海岸通1丁目5番1号
  許可の種類 : 第一種医療機器製造販売業
  許可番号 : 28B1X10014


4.改修理由
 

当該装置において、装置の設置時あるいは採用試薬変更時に、当該試薬にあわせてパラメータを設定しますが、一部の装置で誤ったパラメータを設定されていることが判明致しました。誤ったパラメータによる測定バラつきは、装置や試薬の再現性範囲内ではあるものの、誤った測定結果による臨床判断への影響を否定できないため、対象装置に対して設定値の確認、必要に応じて設定修正を行う自主改修を実施いたします。



5.危惧される具体的な健康被害
 
本不具合が発生した場合、誤った測定結果を出力する可能性が考えられますが、測定結果は検査技師、医師によって確認された上で他の検査、診察結果と併せて疾病の診断に用いられますので、重篤な健康被害の可能性はないと判断します。なお、これまでに本不具合による健康被害発生の報告は受けておりません。
   
 
6.改修開始年月日
 

令和元年8月1日

   
 

7.効能・効果又は用途等

 
(1)全自動血液凝固測定装置 CA-500シリーズ
(2)全自動血液凝固測定装置 CA-600シリーズ
(3)全自動血液凝固測定装置 CA-1500
(4)全自動血液凝固測定装置 CA-6000
(5)全自動血液凝固測定装置 CA-8000
当該製品は、フィブリノーゲン、フィブリン等の止血(出血の抑制)成分の定性・定量や止血時間の計測を行う自動の装置である。

(6)全自動血液凝固測定装置 CA-7000
本装置はヒトの抗凝固剤(クエン酸ナトリウム)加血液の血漿成分の凝固を測定する。但し、FDP測定については血漿、または、血清検査。

 

8. その他

  対象製品の出荷先は全て特定できておりますので、情報提供すると共に適切に改修を実施いたします。

以上