Device Recall Vitek 2 ASTYS06 REF 412 610

  • Model / Serial
    lot 286303720, expiration 08-APR-15
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
  • Product Description
    Vitek 2 AST-YS06 REF 412 610, Fungal 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 clinically significant yeasts to antifungal agents when used as instructed.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Manufacturer Parent Company (2017)
  • Source
    USFDA