Device Recall VITROS Immunodiagnostics Products HBsAg Reagent Pack

  • 모델명 / 제조번호(시리얼번호)
    Lots 6000 and 6030 thru 6120
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including Puerto Rico and countries of Tortola (British Virgin Islands) and Anguilla.
  • 제품 설명
    VITROS¿ Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ortho-Clinical Diagnostics, Forest Farm Estate, Whitechurch, Cardiff United Kingdom
  • Source
    USFDA