Device Recall Abbott Diabetes Care, MediSense Optium

  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 45001A159, 45001A195, 45001A228, 45001A233, 45001A236, 45001A243, 45001A247, 45001A249,  45001A250, 45001A255, 45001A279, 45001A285, 45001A295, 45001A298, 45001A306, 45001A317, 45001A318, 45001A327, 45001A346, 45001A398, 45001A449, 45001A469, 45001A578, 45001A693,  45001A697, 45001A747, 45001A790, 45001A795, 45001A839, 45001A917; MediSense Optium Blood Glucose Electrodes: 45001A133, 45001A137, 45001A226, 45001A252, 45001A257, 45001A277, 45001A285, 45001A817, 45001A835, 45001A921, 45001C001.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Products were released for distribution in US and Puerto Rico.
  • 제품 설명
    Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; || MediSense Optium Blood Glucose Electrodes;
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA