BEUDAMED
    FDA Recall Terminated

    VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: 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.

    Recall: Z-3179-2018 · Initiated August 13, 2018

    Recall

    Recall Number
    Z-3179-2018
    Event Number
    80860
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    LCD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 13, 2018
    Terminated
    November 2, 2020
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: 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.

    Reason

    Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).

    Action

    The firm initiated the recall by email on 08/13/2018. The firm requested the consignee discard the impacted product and contact the local bioMerieux representative for credit.

    Distribution

    Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,

    Quantity

    2538 cartons