BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2278-2015 · Initiated June 26, 2015

    Recall

    Recall Number
    Z-2278-2015
    Event Number
    71602
    Firm
    Hardy Diagnostics
    FEI Number
    2022807
    Product Code
    JSO
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    June 26, 2015
    Posted
    July 29, 2015
    Terminated
    September 11, 2015
    Address
    1430 W Mccoy Ln, Santa Maria, CA, 93455-1005

    Description

    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

    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.

    Action

    The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinung the product and as part of the process were recalling anything that still might be within expiration date. The instructions provided via phone were to discard any remaining plates that are in stock in order for credit. The phone script stated that the firm was going to be sending something in writing. On 06/25-29/15 the firm sent out notification letters to customers to inform them that they were discontuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the endlosed form stating their compliance with the above action. The notification states if the laboratory was unable to be reached via telephone and would like a credit to contact the Customer Service Department at 800-266-2222, option 1. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at [email protected]. Follow-up calls will be made to customers who do not respond.

    Distribution

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

    Quantity

    100 each and 1,860 each (186 pk/10)