BEUDAMED
    FDA Enforcement Class II Terminated

    Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.

    Recall: Z-2276-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2276-2015
    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 BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.

    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: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103

    Distribution

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

    Quantity

    5,940 (5940 pk/10)