Device Recall BioPlex 2200 EBV IgM on the BioPlex 2200 MultiAnalyte

  • Modelo / Serial
    Lot Numbers: 943712 Exp. 7/30/07 and 943713 Exp. 4/30/08
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland.
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA