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一般名及び販売名
１）一般名： 汎用血液ガス分析装置 販売名：血液ガスシステム ＡＢＬ８００ＦＬＥＸ ２）一般名： 汎用血液ガス分析装置 販売名：血液ガスシステム ＡＢＬ８３５ＦＬＥＸ ３）一般名： 汎用血液ガス分析装置 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 ３６台 出荷年月： 平成17年3月〜平成17年9月 シリアル番号： 754R0007N005 754R0007N010 754R0009N003 754R0010N003 754R0010N005 754R0041N004 754R0041N010 754R0042N001 754R0042N002 754R0042N003 754R0042N006 754R0065N003 754R0066N009 754R0068N003 754R0068N007 754R0074N002 754R0074N004 754R0074N009 754R0076N006 754R0083N001 754R0084N002 754R0084N004 754R0084N006 754R0089N003 754R0089N004 754R0089N010 754R0091N001 754R0096N001 754R0096N004 754R0099N003 754R0099N010 754R0106N003 754R0111N002 754R0117N005 754R0117N006 754R0119N002 ２）販売名：血液ガスシステム ＡＢＬ８３５ＦＬＥＸ １０台 出荷年月： 平成17年5月〜平成17年8月 シリアル番号： 754R0076N008 754R0119N001 754R0092N009 754R0092N003 754R0117N003 754R0117N001 754R0076N009 754R0098N007 754R0098N009 754R0117N002 ３）販売名：血液ガスシステム ＡＢＬ７００シリーズ ７３２台 出荷年月： 平成10年11月〜平成17年7月 441R0008N007 441R0009N007 441R0011N008 441R0012N007 441R0013N002 441R0013N008 441R0015N002 441R0015N005 441R0016N003 441R0017N001 441R0020N002 441R0022N003 441R0022N008 441R0023N004 441R0023N010 441R0024N003 441R0024N009 441R0025N001 441R0025N002 441R0025N008 441R0030N001 441R0030N005 441R0030N006 441R0030N008 441R0030N010 441R0031N004 441R0033N003 441R0033N005 441R0034N001 441R0034N003 441R0034N006 441R0034N010 441R0035N001 441R0036N002 441R0037N007 441R0038N008 441R0043N005 441R0044N002 441R0044N006 441R0046N005 441R0046N009 441R0050N004 441R0050N009 441R0051N001 441R0051N008 441R0051N010 441R0052N002 441R0052N005 441R0052N009 441R0053N008 441R0054N001 441R0055N001 441R0055N004 441R0056N001 441R0056N003 441R0056N005 441R0056N008 441R0057N009 441R0057N010 441R0058N007 441R0058N008 441R0059N002 441R0071N007 441R0074N007 441R0074N010 441R0075N002 441R0075N003 441R0076N002 441R0076N003 441R0076N010 441R0077N004 441R0077N007 441R0077N010 441R0078N002 441R0078N004 441R0079N002 441R0079N003 441R0079N004 441R0079N006 441R0079N007 441R0079N009 441R0080N001 441R0080N002 441R0080N003 441R0080N005 441R0080N009 441R0080N010 441R0081N002 441R0081N003 441R0082N002 441R0082N003 441R0082N005 441R0082N007 441R0083N003 441R0083N008 441R0083N009 441R0084N005 441R0084N009 441R0106N003 441R0106N005 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 441R0143N001 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 441R0172N009 441R0172N010 441R0173N002 441R0173N004 441R0173N007 441R0173N008 441R0173N010 441R0191N003 441R0191N007 441R0192N007 441R0192N008 441R0193N005 441R0193N006 441R0193N008 441R0193N009 441R0193N010 441R0194N009 441R0197N003 441R0197N005 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 441R0243N002 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 441R0276N008 441R0276N009 441R0301N007 441R0301N008 441R0301N010 441R0302N003 441R0302N006 441R0306N002 441R0306N004 441R0306N005 441R0306N006 441R0306N009 441R0307N002 441R0307N004 441R0307N008 441R0308N004 441R0308N006 441R0308N007 441R0309N004 441R0309N006 441R0309N008 441R0309N009 441R0309N010 441R0310N003 441R0310N004 441R0311N004 441R0311N006 441R0311N007 441R0312N010 441R0313N001 441R0313N006 441R0314N003 441R0314N004 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 441R0341N006 441R0341N009 441R0360N005 441R0360N008 441R0360N010 441R0361N003 441R0361N006 441R0361N009 441R0362N002 441R0362N003 441R0362N005 441R0363N007 441R0369N003 441R0370N006 441R0371N001 441R0372N006 441R0377N007 441R0379N004 441R0383N006 441R0384N003 441R0384N006 441R0385N002 441R0385N003 441R0385N005 441R0385N006 441R0385N008 441R0385N009 441R0385N010 441R0387N001 441R0387N002 441R0387N003 441R0387N009 441R0387N010 441R0388N006 441R0389N001 441R0389N003 441R0390N004 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 441R0541N009 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 441R0602N009 441R0602N010 441R0608N006 441R0608N008 441R0608N010 441R0609N003 441R0609N009 441R0614N006 441R0614N008 441R0616N001 441R0616N006 441R0617N001 441R0617N002 441R0617N004 441R0617N005 441R0617N006 441R0617N007 441R0617N009 441R0617N010 441R0618N003 441R0619N001 441R0619N002 441R0621N001 441R0621N002 441R0621N003 441R0621N004 441R0621N006 441R0621N007 441R0621N008 441R0621N009 441R0621N010 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 441R0669N008 441R0672N001 441R0672N002 441R0672N003 441R0672N004 441R0673N003 441R0674N001 441R0674N004 441R0674N008 441R0674N010 441R0676N001 441R0676N002 441R0676N003 441R0676N004 441R0676N005 441R0677N001 441R0677N002 441R0677N003 441R0677N004 441R0677N005 441R0677N006 441R0677N007 441R0677N008 441R0677N009 441R0677N010 441R0680N001 441R0680N003 441R0680N005 441R0680N010
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ApS（デンマーク国）
回収理由
「血液ガスシステムＡＢＬ７００シリーズ」において、溶液を制御する電磁バルブに使用 されているラバー製メンブランに発生したピンホールにより、電位差測定系の電位がアー スへリークし、この測定系で動作しているカルシウムならびにナトリウムが低値に測定さ れる故障現象が海外において２件発生しました。安全を考えこのリーク電流の検出機能を ソフトウエアに追加し、定時キャリブレーション動作において新しいソフトウエア故障の 検出を行い、エラーが発生した場合測定結果へフラグを付加する改修を行います。 尚、「血液ガスシステム ＡＢＬ８００ＦＬＥＸ」および「血液ガスシステム ＡＢＬ８ ３５ＦＬＥＸ」も同様の機構を搭載している製品を改修の対象といたします。
危惧される具体的な健康被害
この故障現象が検体測定中に発生した場合、その検体結果がエラーとフラグされないで表 示される可能性があります。しかし、本医療機器の測定結果は、他の臨床上の情報などと 総合的に判断して行われ、本医療機器の測定値のみで診断や医療処置が行われるものでは ありませんので、本不具合による患者の重篤な健康被害の発生はないものと考えておりま す。 現在までのところ、国内外において本不具合による患者様の重篤な健康被害の報告はござ いません。
回収開始年月日
平成17年9月21日（情報提供の開始）
効能・効果又は用途等
本製品は、採血された全血の血液ガス、電解質、オキシメトリー、代謝項目等を測定する 分析装置です。
その他
当該製品の納入先は全て特定しておりますので、弊社社員が納入しました医療機関を訪問 し自主改修を行います。
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： 柳澤 仁志、島貫 長次