Device Recall ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM 33340, 33345

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  716707, 720541,  720542,  721451,  721452,  722677,  722678,  821024,  821025,  821515, 821663, 823314, 823523, 823524, 823850, 825783, 825784, 826258, 826259, 827876, 828479, 829974, 831218, 850000,  850003, 850004, 850005, 850010, 850011, 850013, 908322, 908323, 908917, 908918, 909803, 909804, 911338, 911339, 911748, 912628, 912629, 913131, 913132, 913265, 913274, 913500, 913821, 914632, 915132, 915417, 915670, 915850, 916720, 916721,  916721A,  917611, 918460 Note: These Lot Numbers represent all reagent lots released to field that could be used in conjunction with Unicel DxI Access Immunoassay Systems.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and Canada
  • 제품 설명
    Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340; Calibrator Part Number: 33345 || The intended use: The Access AccuTnI assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac Troponin I determination also aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
  • Source
    USFDA