Device Recall VRE Broth

  • Model / Serial
    Lot number: 15021, 15043, 15072, 15126, 15152 Cat no. K103
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide Distribution and the country of: Canada
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Hardy Diagnostics, 1430 W Mccoy Ln, Santa Maria CA 93455-1005
  • Manufacturer Parent Company (2017)
  • Source
    USFDA