BEUDAMED
    FDA Recall Terminated

    Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

    Recall: Z-1402-2015 · Initiated February 25, 2015

    Recall

    Recall Number
    Z-1402-2015
    Event Number
    70645
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LTW
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 25, 2015
    Posted
    April 8, 2015
    Terminated
    March 22, 2017
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

    Reason

    The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

    Action

    Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " For the referenced test kits (VITEK 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in the Package Insert antibiotic table to confirm which organisms can be tested. " Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae. " Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms. " Please store this letter with your bioMrieux instrument documentation. Please complete the attached Acknowledgement Form and return it to bioMrieux, Inc. Customers with questions were instructed to contact their local BioMerieux representative. For questions regarding this recall call 314-731-8526.

    Distribution

    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.

    Quantity

    2053 cartons