Device Recall Directigen (TM) EZ RSV

  • Modèle / numéro de série
    lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.
  • Description du dispositif
    Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Société-mère du fabricant (2017)
  • Source
    USFDA