Device Recall Vitek 2 ASTP641 REF 418 590

  • 모델명 / 제조번호(시리얼번호)
    lot 741350820, expiration 22JUL16; lot 741340920, expiration 14APR16;
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
  • 제품 설명
    Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • 제조사 모회사 (2017)
  • Source
    USFDA