Device Recall Roche ACCUCHEK Performa blood glucose meter

  • 모델명 / 제조번호(시리얼번호)
    All Lots with REF Numbers: 4861574019, 4861574020, 4861582014, 4861582019, 4861582020, 4861582034, 4862015023, 4862015027 and 4929381023.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela.
  • 제품 설명
    Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. || Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA