BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2279-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2279-2015
    Event ID
    71602
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hardy Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 5, 2015
    Initiation Date
    June 26, 2015
    Classification Date
    July 29, 2015
    Termination Date
    September 11, 2015
    Address
    1430 W Mccoy Ln, N/A, Santa Maria, CA, 93455-1005, United States

    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.

    Reason

    Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.

    Code Info

    Lot number: 15021, 15043, 15072, 15126, 15152 Cat no. K103

    Distribution

    U.S. Nationwide Distribution and the country of: Canada

    Quantity

    900 each (90 pk/10)