Device Recall VITEK 2 Compact 15

  • Model / Serial
    VITEK¿ 2 Compact 15 and Compact 30 instruments previously manufactured/installed with VITEK¿ 2 System software versions prior to 5.01, and currently being upgraded to version 8.01.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
  • Manufacturer
  • 1 Event

Manufacturer

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