BEUDAMED
    FDA Recall Terminated

    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is 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 to antimicrobial agents when used as instructed in the Product Information manual.

    Recall: Z-1596-2016 · Initiated February 24, 2016

    Recall

    Recall Number
    Z-1596-2016
    Event Number
    73585
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2016
    Posted
    May 3, 2016
    Terminated
    May 26, 2017
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is 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 to antimicrobial agents when used as instructed in the Product Information manual.

    Reason

    Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.

    Action

    Biomerieux, Inc. sent an Urgent Notice Product Correction on February 24, 2016, to all affected customers. The recalling firm notified their foreign subsidiary of the Field Safety Corrective Action (FSCA) by email. The local subsidiary in the country impacted has informed users impacted and provided instructions to resolve the issue. Customers were instructed to confirm the Field Safety Corrective Action letter has been distributed and reviewed by all appropriate personnel within their organization. For the referenced test kit (VITEK 2 ASTP605, Lot 485368220), refrain from reporting Minocycline (MNO) results for any organism until a new lot is implemented in your laboratory. o Please note that a bioART rule can be created to suppress the analysis/reporting of Minocycline (reference VITEK 2 Online Software User Manual). The bioART rule can be disabled upon implementation of a new ASTP605 lot number. Customers were instructed tostore the letter with their bioMrieux instrument documentation. Complete the attached Acknowledgement Form and return it to their local bioMrieux representative. For questions regarding this recall call 314-731-8526.

    Distribution

    Worldwide Distribution to China Taiwan region; No US/military/government distribution.

    Quantity

    337 Kits of 20 Cards/Kit