一般名及び販売名

一般名：汎用血液ガス分析装置
(1) 販売名：血液ガスシステムABL800FLEX
(2) 販売名：血液ガスシステムABL835FLEX
(3) 販売名：ABL800FLEXシステム
(4) 販売名：血液ガスシステム ABL700シリーズ

対象ロット、数量及び出荷時期

(1) 販売名：血液ガスシステムABL800FLEX
出荷年月日：平成17年3月28日~平成18年9月27日
製造番号：
754R0007N005	754R0007N010	754R0009N003	754R0010N003	754R0010N005
754R0041N004	754R0041N010	754R0042N001	754R0042N002	754R0042N003
754R0042N005	754R0042N006	754R0065N003	754R0065N005	754R0066N006
754R0066N007	754R0066N008	754R0066N009	754R0068N003	754R0068N007
754R0069N003	754R0072N001	754R0072N005	754R0074N002	754R0074N004
754R0074N005	754R0074N006	754R0074N009	754R0076N006	754R0076N007
754R0078N010	754R0083N001	754R0084N002	754R0084N003	754R0084N004
754R0084N006	754R0089N004	754R0089N010	754R0091N001	754R0096N001
754R0096N004	754R0098N008	754R0099N003	754R0099N010	754R0104N001
754R0104N010	754R0106N003	754R0106N006	754R0106N010	754R0110N001
754R0110N002	754R0111N002	754R0115N004	754R0115N006	754R0115N008
754R0115N010	754R0116N009	754R0117N005	754R0117N006	754R0119N003
754R0119N004	754R0119N005	754R0122N009	754R0122N010	754R0123N002
754R0123N007	754R0123N010	754R0124N004	754R0124N009	754R0124N010
754R0125N002	754R0125N007	754R0127N001	754R0138N001	754R0138N003
754R0138N004	754R0138N005	754R0144N008  754R0125N001**754R0125N003**
754R0125N004**
出荷台数：　81台（**）

(2) 販売名：血液ガスシステムABL835FLEX
出荷年月日：平成17年5月27日~平成19年5月25日
製造番号：
754R0076N008	754R0076N009	754R0089N003	754R0092N003	754R0092N009
754R0098N007	754R0098N009	754R0117N001	754R0117N002	754R0117N003
754R0119N001	754R0119N002	754R0123N001	754R0138N002	754R0144N001
754R0144N006	754R0144N007	754R0144N009	754R0144N010	754R0148N008
754R0149N001	754R0149N002	754R0149N003	754R0149N004	754R0149N010
754R0151N002	754R0151N010	754R0152N001	754R0152N003	754R0152N004
754R0152N005	754R0152N008	754R0152N009	754R0152N010	754R0155N001
754R0155N010	754R0161N003	754R0163N002	754R0163N005	754R0164N003
754R0164N004	754R0164N005	754R0165N005	754R0167N005	754R0167N008
754R0167N010	754R0168N001	754R0168N002	754R0168N003	754R0168N004
754R0174N006	754R0191N001	754R0191N002	754R0191N003	754R0196N008
754R0197N001	754R0197N011	754R0198N007	754R0198N011	754R0198N012
754R0199N006	754R0199N007	754R0199N008	754R0199N012	754R0200N001
754R0200N002	754R0200N003	754R0200N005	754R0201N009	754R0204N003
754R0204N007	754R0204N008	754R0204N009	754R0204N011	754R0204N012
754R0205N001	754R0205N004	754R0206N002	754R0206N004	754R0206N005
754R0206N006	754R0206N008	754R0206N010	754R0207N007	754R0210N004
754R0210N008	754R0210N009	754R0211N002	754R0213N006	754R0213N007
754R0213N008	754R0213N010	754R0213N011	754R0214N002	754R0214N007
754R0214N009	754R0214N010	754R0215N002	754R0215N009	754R0216N002
754R0216N010	754R0217N003	754R0217N004	754R0218N004	754R0218N007
754R0218N008	754R0219N003	754R0220N010	754R0225N001	754R0225N012
754R0227N003	754R0227N004	754R0227N005	754R0227N007	754R0227N008
754R0227N009	754R0227N010	754R0227N011	754R0232N012	754R0233N011
754R0237N002	754R0237N006	754R0237N008	754R0237N011	754R0238N006
754R0249N010	754R0261N006  754R215N004**
出荷台数：　128台（**）

(3) 販売名：ABL800FLEXシステム
出荷年月日：平成18年8月24日~平成20年1月25日
製造番号：
754R0216N001	754R0219N004	754R0237N004	754R0238N005	754R0240N002
754R0243N011	754R0244N011	754R0245N002	754R0245N003	754R0249N006
754R0249N011	754R0249N012	754R0250N001	754R0250N003	754R0250N005
754R0250N006	754R0250N007	754R0250N010	754R0251N002	754R0251N009
754R0252N001	754R0252N007	754R0253N003	754R0255N004	754R0255N009
754R0259N012	754R0260N007	754R0261N003	754R0261N007	754R0262N004
754R0262N005	754R0262N007	754R0263N004	754R0263N008	754R0263N010
754R0263N011	754R0263N012	754R0264N001	754R0264N002	754R0264N004
754R0264N009	754R0265N009	754R0265N010	754R0267N001	754R0267N004
754R0267N005	754R0267N007	754R0267N010	754R0268N001	754R0268N002
754R0268N003	754R0271N009	754R0271N011	754R0272N002	754R0272N003
754R0272N004	754R0272N005	754R0272N006	754R0272N008	754R0273N009
754R0278N003	754R0281N001	754R0292N001	754R0298N009	754R0298N012
754R0305N001	754R0305N004	754R0314N002	754R0314N006	754R0315N001
754R0315N005	754R0315N012	754R0316N007	754R0316N009	754R0316N010
754R0316N011	754R0317N001	754R0317N003	754R0317N004	754R0317N005
754R0319N001	754R0319N002	754R0319N003	754R0319N004	754R0319N005
754R0319N006	754R0319N007	754R0319N008	754R0321N005	754R0321N007
754R0321N008	754R0326N004	754R0326N011	754R0328N004	754R0331N007
754R0333N012	754R0334N001	754R0335N007	754R0337N004	754R0338N011
754R0339N005	754R0339N006	754R0339N011	754R0340N008	754R0340N009
754R0341N001	754R0341N012	754R0345N004	754R0345N005	754R0346N002
754R0346N003	754R0346N004	754R0346N008	754R0346N009	754R0346N011
754R0346N012	754R0353N001	754R0363N002	754R0363N007	754R0363N011
754R0364N001	754R0364N003	754R0364N004	754R0364N005	754R0364N008
754R0365N004	754R0367N009	754R0367N011	754R0368N009	754R0368N011
754R0368N012	754R0369N003	754R0369N008	754R0369N010	754R0369N011
754R0369N012	754R0373N010	754R0373N011	754R0373N012	754R0377N011
754R0377N012	754R0378N005	754R0379N004	754R0379N012	754R0380N004
754R0380N005	754R0380N006	754R0380N008	754R0388N010	754R0393N010
754R0395N003	754R0396N004	754R0396N005	754R0396N006	754R0396N009
754R0403N036	754R0404N008	754R0404N010	754R0404N012	754R0405N005
754R0408N008	754R0408N011	754R0408N012	754R0409N001	754R0409N002
754R0410N001	754R0410N011	754R0417N011	754R0423N004	754R0424N007
754R0428N006	754R0432N006	754R0432N009	754R0440N002  754R0245N006**
754R0253N004**754R0271N008**754R0289N001**754R0317N010**754R0320N006**
754R0320N009**754R0320N010**754R0321N006**754R0321N009**754R0325N004**
754R0339N004**754R0343N001**754R0346N005**754R0357N001**754R0357N002**
754R0360N010**754R0364N002**754R0375N012**754R0380N002**754R0386N007**
754R0388N009**754R0389N002**754R0389N003**754R0390N007**754R0390N008**
754R0392N002**754R0396N001**754R0398N011**754R0404N009**754R0404N011**
754R0410N010**754R0410N012**754R0414N003**754R0414N004**754R0414N005**
754R0414N006**754R0414N008**754R0414N011**754R0415N003**
出荷台数： 214台（**）

(4) 販売名：血液ガスシステム ABL700シリーズ
出荷年月日：平成10年12月25日~平成17年12月28日
製造番号：(*は、Windows95のOSで稼動)
441R0008N007*	441R0009N007*	441R0011N008*	441R0012N007*	441R0013N002*
441R0013N008*	441R0015N002*	441R0015N005*	441R0016N003*	441R0017N001*
441R0020N002*	441R0022N003*	441R0022N008*	441R0023N004*	441R0023N010*
441R0024N003*	441R0024N009*	441R0025N002*	441R0025N008*	441R0030N001*
441R0030N005*	441R0030N006*	441R0030N008*	441R0030N010*	441R0031N004*
441R0033N003*	441R0033N005*	441R0034N001*	441R0034N003*	441R0034N006*
441R0034N010*	441R0035N001*	441R0036N002*	441R0037N007*	441R0038N008*
441R0043N005*	441R0044N002*	441R0046N005*	441R0046N009*	441R0050N004*
441R0050N009*	441R0051N001*	441R0051N008*	441R0051N010*	441R0052N002*
441R0052N005*	441R0052N009*	441R0053N008*	441R0054N001*	441R0055N001*
441R0055N004*	441R0056N001*	441R0056N003*	441R0056N005*	441R0056N008*
441R0057N009*	441R0058N007*	441R0058N008*	441R0059N002*	441R0071N007*
441R0074N007*	441R0075N002*	441R0075N003*	441R0076N002*	441R0076N003*
441R0076N010*	441R0077N004*	441R0077N007	441R0077N010*	441R0078N002*
441R0078N004*	441R0078N008*	441R0079N002*	441R0079N003*	441R0079N004*
441R0079N006*	441R0079N007*	441R0079N009*	441R0080N001*	441R0080N002*
441R0080N003*	441R0080N009*	441R0081N002*	441R0081N003*	441R0082N002*
441R0082N003	441R0082N005*	441R0082N007*	441R0083N003*	441R0083N008*
441R0083N009*	441R0084N005*	441R0084N009*	441R0106N003*	441R0108N003*
441R0108N006*	441R0108N007*	441R0109N001*	441R0109N003* 441R0109N004*
441R0109N006*	441R0114N008*	441R0115N004*	441R0115N010*	441R0116N006*
441R0117N001*	441R0117N004*	441R0117N010*	441R0118N001*	441R0118N004*
441R0119N003*	441R0123N010*	441R0124N002*	441R0125N003*	441R0125N005*
441R0126N001	441R0126N008*	441R0128N007*	441R0129N004*	441R0129N005*
441R0130N001*	441R0130N005*	441R0131N004*	441R0131N010*	441R0132N001*
441R0132N002*	441R0132N009*	441R0133N001*	441R0133N006*	441R0133N007*
441R0134N001*	441R0138N005*	441R0138N007*	441R0140N002*	441R0140N003*
441R0140N008*	441R0140N010*	441R0141N005*	441R0141N009*	441R0144N004*
441R0144N009*	441R0145N007*	441R0147N002*	441R0147N003*	441R0147N004*
441R0147N006*	441R0147N010*	441R0153N002*	441R0153N003*	441R0153N004*
441R0153N008*	441R0153N010*	441R0155N008*	441R0158N009*	441R0159N002*
441R0159N004*	441R0159N009*	441R0168N001*	441R0168N002*	441R0168N003
441R0168N005*	441R0168N007*	441R0168N008*	441R0169N003*	441R0169N004*
441R0169N006*	441R0169N007*	441R0169N008*	441R0169N009*	441R0169N010*
441R0170N001*	441R0170N006*	441R0172N004*	441R0172N005*	441R0172N008*
441R0172N010*	441R0173N002*	441R0173N004*	441R0173N007*	441R0173N008*
441R0173N010*	441R0191N003*	441R0191N007*	441R0192N007*	441R0192N008*
441R0193N005*	441R0193N006*	441R0193N008*	441R0193N009*	441R0193N010*
441R0194N009*	441R0197N003*	441R0198N001*	441R0198N005*	441R0198N006*
441R0198N007*	441R0198N008*	441R0198N010*	441R0199N001*	441R0199N004*
441R0203N004*	441R0203N005*	441R0203N010*	441R0204N002*	441R0204N003*
441R0204N004*	441R0204N005*	441R0204N010*	441R0205N004*	441R0205N006*
441R0209N010*	441R0211N010*	441R0212N005*	441R0213N008*	441R0214N002*
441R0214N005*	441R0214N010*	441R0215N010*	441R0216N002*	441R0216N009
441R0221N010*	441R0222N003*	441R0222N004*	441R0222N010*	441R0223N001*
441R0223N003*	441R0223N004*	441R0223N006*	441R0223N007*	441R0223N008*
441R0242N002*	441R0242N008*	441R0243N004*	441R0243N009*	441R0246N010*
441R0247N001*	441R0247N005*	441R0247N007*	441R0247N009*	441R0259N002*
441R0259N003*	441R0260N002*	441R0260N007*	441R0261N008*	441R0265N003*
441R0265N004*	441R0266N001*	441R0266N003*	441R0266N006*	441R0267N003*
441R0267N005*	441R0267N006*	441R0267N007*	441R0267N008*	441R0271N001*
441R0271N002*	441R0271N005*	441R0271N006*	441R0271N007*	441R0271N008*
441R0271N010*	441R0272N002*	441R0272N005*	441R0272N009*	441R0274N008*
441R0275N004*	441R0275N009*	441R0276N001*	441R0276N003*	441R0276N004*
441R0276N005*	441R0276N006*	441R0276N009*	441R0301N007*	441R0301N008*
441R0301N010*	441R0302N003*	441R0302N006*	441R0306N002*	441R0306N004*
441R0306N005*	441R0306N006*	441R0306N009*	441R0307N002*	441R0307N004*
441R0307N008*	441R0308N004*	441R0308N006*	441R0308N007*	441R0309N004*
441R0309N008*	441R0309N009*	441R0309N010*	441R0310N003*	441R0310N004*
441R0311N004*	441R0311N006*	441R0311N007*	441R0312N010*	441R0313N001*
441R0313N006*	441R0315N006*	441R0317N005*	441R0317N006*	441R0318N003*
441R0318N008*	441R0321N002*	441R0321N006*	441R0321N007*	441R0321N009*
441R0322N005*	441R0323N003*	441R0323N004*	441R0323N007*	441R0323N008*
441R0328N003*	441R0328N009*	441R0329N004*	441R0329N005*	441R0329N008*
441R0330N001*	441R0330N004*	441R0330N005*	441R0330N007*	441R0330N008*
441R0330N009*	441R0330N010*	441R0331N001*	441R0331N002*	441R0331N005*
441R0332N001*	441R0332N003*	441R0332N007*	441R0333N003*	441R0334N009*
441R0338N007*	441R0339N001*	441R0339N002*	441R0339N004*	441R0339N005*
441R0339N007*	441R0339N008*	441R0339N010	441R0340N001*	441R0340N002*
441R0340N007*	441R0340N008*	441R0341N001*	441R0341N004*	441R0341N009*
441R0360N005*	441R0360N008*	441R0360N010*	441R0361N003*	441R0361N006*
441R0361N009*	441R0362N002*	441R0362N003*	441R0362N005*	441R0363N007*
441R0370N006*	441R0371N001*	441R0372N006*	441R0377N007*	441R0379N004*
441R0383N006*	441R0384N003*	441R0384N006*	441R0385N002	441R0385N003*
441R0385N005*	441R0385N006*	441R0385N008*	441R0385N009*	441R0385N010*
441R0387N001*	441R0387N002*	441R0387N003*	441R0387N009*	441R0387N010*
441R0388N006*	441R0389N003*	441R0391N003*	441R0391N008*	441R0391N010*
441R0392N001*	441R0392N002*	441R0392N003*	441R0392N009*	441R0393N006*
441R0393N007*	441R0393N008*	441R0394N006*	441R0395N004*	441R0395N005*
441R0395N010*	441R0396N003*	441R0407N001*	441R0410N002*	441R0416N002*
441R0416N003*	441R0416N006*	441R0416N009	441R0416N010*	441R0417N003*
441R0417N004*	441R0418N003*	441R0418N010*	441R0420N004*	441R0420N007*
441R0421N004*	441R0421N005*	441R0422N003*	441R0422N004*	441R0422N008*
441R0422N010*	441R0423N001*	441R0423N005*	441R0423N009*	441R0424N003*
441R0426N003*	441R0426N008*	441R0428N006*	441R0429N005*	441R0430N003*
441R0430N008*	441R0431N008*	441R0432N004*	441R0432N007	441R0432N008*
441R0432N009*	441R0432N010*	441R0439N004*	441R0444N006*	441R0444N007*
441R0446N003*	441R0446N006*	441R0448N002*	441R0448N006*	441R0448N008*
441R0448N009*	441R0448N010*	441R0449N008*	441R0454N007*	441R0457N008*
441R0459N001*	441R0459N004*	441R0459N008*	441R0459N009*	441R0470N002*
441R0470N007*	441R0470N008*	441R0470N010*	441R0472N004*	441R0474N001*
441R0474N004*	441R0474N006*	441R0474N007*	441R0474N010*	441R0475N009*
441R0479N007*	441R0480N003*	441R0480N004*	441R0480N005*	441R0480N006*
441R0483N003*	441R0487N005*	441R0487N008*	441R0487N009*	441R0489N005*
441R0489N008*	441R0490N003*	441R0490N004*	441R0492N002*	441R0492N010*
441R0493N001*	441R0493N004*	441R0493N005*	441R0493N006*	441R0493N007*
441R0493N008*	441R0493N009*	441R0493N010*	441R0496N002*	441R0496N003*
441R0496N006*	441R0496N009*	441R0496N010*	441R0501N004*	441R0503N002*
441R0503N010*	441R0504N001*	441R0504N002*	441R0504N003*	441R0504N004*
441R0506N002*	441R0506N003*	441R0506N006*	441R0507N002*	441R0507N003*
441R0507N004*	441R0507N005*	441R0507N007*	441R0507N009*	441R0508N004*
441R0508N006*	441R0508N007*	441R0511N003*	441R0511N005*	441R0512N008*
441R0515N003*	441R0515N004*	441R0515N005*	441R0515N007*	441R0516N002*
441R0516N003*	441R0516N004*	441R0516N007*	441R0516N010*	441R0518N006*
441R0518N010*	441R0521N002*	441R0521N003*	441R0521N010*	441R0522N010*
441R0531N004*	441R0531N006*	441R0538N006	441R0538N008*	441R0538N009*
441R0538N010*	441R0541N002*	441R0541N005*	441R0541N006*	441R0545N002*
441R0545N003*	441R0545N006*	441R0545N007*	441R0545N010*	441R0547N007
441R0547N008*	441R0556N001*	441R0556N002*	441R0556N003*	441R0556N004*
441R0556N005*	441R0556N006*	441R0556N007*	441R0556N008*	441R0556N009*
441R0556N010*	441R0558N005*	441R0559N001	441R0560N010*	441R0563N008*
441R0565N002*	441R0566N007*	441R0566N008*	441R0567N002*	441R0567N003*
441R0567N004*	441R0567N005*	441R0567N006*	441R0567N007*	441R0567N008*
441R0567N009*	441R0567N010*	441R0568N004*	441R0569N008*	441R0572N006*
441R0573N001*	441R0575N001*	441R0575N002*	441R0575N003*	441R0575N004*
441R0575N005*	441R0575N007*	441R0575N008*	441R0575N010*	441R0578N010*
441R0579N006*	441R0583N001*	441R0583N003*	441R0583N010*	441R0584N001*
441R0584N004*	441R0584N005*	441R0584N006*	441R0584N007*	441R0584N008*
441R0584N010*	441R0585N002*	441R0588N002*	441R0590N002*	441R0590N003*
441R0590N004*	441R0590N005*	441R0590N006*	441R0590N007*	441R0590N009*
441R0590N010	441R0595N001*	441R0595N008*	441R0596N002*	441R0596N004*
441R0596N007*	441R0596N009*	441R0596N010*	441R0597N005*	441R0597N006
441R0597N010*	441R0601N008*	441R0602N001*	441R0602N002*	441R0602N004
441R0602N008*	441R0602N009*	441R0602N010	441R0608N006*	441R0608N008*
441R0608N010*	441R0609N003*	441R0609N009*	441R0614N006*	441R0614N008*
441R0616N001*	441R0616N006*	441R0617N001*	441R0617N002*	441R0617N004*
441R0617N005	441R0617N006*	441R0617N007*	441R0617N010*	441R0618N003
441R0619N001*	441R0619N002*	441R0621N001*	441R0621N002*	441R0621N003*
441R0621N004*	441R0621N006*	441R0621N007*	441R0621N008*	441R0621N009*
441R0621N010*	441R0625N006*	441R0626N003*	441R0628N002*	441R0628N004*
441R0628N007*	441R0629N005*	441R0629N007*	441R0630N005*	441R0633N002*
441R0633N003	441R0633N004*	441R0633N006	441R0633N007*	441R0633N010*
441R0634N006	441R0634N008*	441R0634N009*	441R0634N010*	441R0635N002
441R0635N003*	441R0635N004*	441R0635N007*	441R0635N009*	441R0645N007*
441R0645N008*	441R0653N002*	441R0653N010*	441R0654N003*	441R0655N005*
441R0659N003*	441R0659N007*	441R0659N008*	441R0668N001	441R0668N002*
441R0668N003*	441R0668N004*	441R0668N005*	441R0668N008*	441R0668N010*
441R0669N005	441R0669N008*	441R0672N001	441R0672N002*	441R0672N003*
441R0672N004*	441R0674N001*	441R0674N004*	441R0674N008*	441R0674N010*
441R0676N001*	441R0676N002*	441R0676N003*	441R0676N004*	441R0676N005*
441R0677N001*	441R0677N002*	441R0677N003	441R0677N004*	441R0677N005*
441R0677N006*	441R0677N007*	441R0677N008	441R0677N009*	441R0677N010*
441R0680N001*	441R0680N002*	441R0680N003*	441R0680N004	441R0680N005*
441R0680N006	441R0680N010
出荷台数： 717台

製造販売業者等名称

名称：	ラジオメーター株式会社
所在地：	東京都港区西新橋3丁目16番11号
薬事の業態：	第2種医療機器製造販売業
製造販売業許可番号：	13B2X00079
輸入先製造業者：	ラジオメーターメディカル社（デンマーク国）

改修理由

海外製造元からの連絡によると上記機種においてキャリブレーション記録数が32,767回を超えるとキャ
リブレーションにエラーがあった場合、そのエラーがスクリーン画面のエラー表示信号と測定結果の
プリントに表示されなくなるとの報告がありました。　また、混入した微小な気泡が酸素電極チャン
バーに付着して、pO2測定データが高値になったという現象が海外にて一件発生しました。　これら
の現象を回避するために安全性情報の提供を行うとともに、エラー表示信号が働かなくなるバグ修正
及び現状の赤外線による気泡検知システムに加えて、新たに微小な気泡の存在を警告するプログラム
を導入します。

危惧される具体的な健康被害

上記の現象によりキャリブレーションエラーを見逃したりpO2の値が高く測定されたりする可能性が
あります。しかし実際の患者判断では血液ガス検査結果だけでなく、各種の検査結果を総合して判断
しますので、直接健康被害が生ずる可能性は極めて低いと考えられます。
また、現在までのところ､日本では同様の不具合の発生およびそれに関連する患者健康被害の報告は
ございません。

改修開始年月日

平成20年2月6日（情報提供の開始）

効能・効果又は用途等

血液ガスシステムABL800FLEX、血液ガスシステムABL835FLEX、ABL800FLEXシステム　血液ガス ABL700
シリーズは、全血中の酸素、二酸化炭素、ｐＨ、ナトリウム、カリウム、クロール、イオン化カルシ
ウム、ラクテート、グルコース、およびオキシメトリーパラメーターを測定する自動測定装置です。

その他

当該製品の納入先は全て特定しておりますので、納入しました医療機関に対して安全性情報と自主回
収情報の提供を行い、その後当該製品のソフトウェアのバージョンアップを実施します。

担当者名及び連絡先

連絡先:ラジオメーター株式会社　QAセンター
東京都港区西新橋3丁目16番11号
電話：03-5777-3503
Fax： 03-5777-3541
担当者名：　西脇