BEUDAMED
    FDA Recall Terminated

    BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose.

    Recall: Z-1043-2009 · Initiated January 13, 2009

    Recall

    Recall Number
    Z-1043-2009
    Event Number
    50821
    Firm
    Lexamed
    FEI Number
    1525897
    Product Code
    LRF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 13, 2009
    Posted
    March 31, 2009
    Terminated
    December 9, 2009
    Address
    705 Front St, Toledo, OH, 43605-2107

    Description

    BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose.

    Reason

    Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.

    Action

    The recalling firm contacted the customer and notified them of this recall via telephone on 1/13/2009, followed by an Urgent Product Recall Notice which was sent to the customer via Certified mail on 1/14/2009. The letter stated the problem with the affected lot and asked that the customer examine their inventory, remove the affected lot, and return the used and unused vial to LexaMed. The customer is to complete and return the enclosed acknowledgement card by mail or fax. Questions should be directed towards Anne Schuler, QA Manager at 419-693-5307 or by e-mail [email protected].

    Distribution

    USA: Utah

    Quantity

    1 vial