Device Recall BioPlex 2200 EBV IgM on the BioPlex 2200 MultiAnalyte

  • Modèle / numéro de série
    Lot Numbers: 943712 Exp. 7/30/07 and 943713 Exp. 4/30/08
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
  • Description du dispositif
    BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Société-mère du fabricant (2017)
  • Source
    USFDA