Device Recall Vitek 2 ASTP641 REF 418 590

  • Modèle / numéro de série
    lot 741350820, expiration 22JUL16; lot 741340920, expiration 14APR16;
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Société-mère du fabricant (2017)
  • Source
    USFDA