Device Recall BEA (Bile Esculin Azide) Broth with Vancomycin

  • Modèle / numéro de série
    Lot number: 15070 Cat no. R98  Lot number: 14193, 14232, 14251, 14272, and 14329 Cat no.: R72
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Nationwide Distribution and the country of: Canada
  • Description du dispositif
    Hardy Diagnostics || BEA Broth with Vancomycin || container type: 13x100mm tube || packaged: 20 tubes/box || fill: 2ml || Product Usage: || BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Hardy Diagnostics, 1430 W Mccoy Ln, Santa Maria CA 93455-1005
  • Société-mère du fabricant (2017)
  • Source
    USFDA