Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack

  • 모델명 / 제조번호(시리얼번호)
    Lot 5040 (Expiry date 19 Dec 2016)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada
  • 제품 설명
    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK || For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
  • Manufacturer
  • 1 Event

제조사

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