Device Recall VRE Broth

  • Modèle / numéro de série
    Lot number: 15021, 15043, 15072, 15126, 15152 Cat no. K103
  • 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 || VRE Broth, 5ml || container type: 16x100mm tube || packaged: 20 tubes/box || fill: 5ml || 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