BEUDAMED
    FDA Recall Terminated

    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

    Recall: Z-1639-2016 · Initiated February 24, 2016

    Recall

    Recall Number
    Z-1639-2016
    Event Number
    73413
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LTW
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    February 24, 2016
    Posted
    May 11, 2016
    Terminated
    March 8, 2018
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

    Reason

    Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

    Action

    Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 2016 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioMrieux representative.

    Distribution

    Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

    Quantity

    495 kits