Device Recall VITEK TWO ASTN085 REF 22 225

  • Model / Serial
    Lot number 345158910 Exp:2011/04/21
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Country of Canada only. No product was distributed in the US.
  • Product Description
    VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMerieux, sa, France.This is an Export Only test kit that is not marketed in the U.S.
  • Manufacturer
  • 1 Event

Manufacturer

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