Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators

  • 모델명 / 제조번호(시리얼번호)
    Lot 1320, Product code: 6800035 and 6800040
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to France and Japan
  • 제품 설명
    VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 || VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
  • 제조사 모회사 (2017)
  • Source
    USFDA