BEUDAMED
    FDA Recall Terminated

    VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101

    Recall: Z-1209-03 · Initiated August 6, 2003

    Recall

    Recall Number
    Z-1209-03
    Event Number
    26945
    Firm
    bioMerieux
    FEI Number
    3002769706
    Product Code
    LJC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 6, 2003
    Posted
    October 15, 2003
    Terminated
    May 17, 2005
    Address
    100 Rodolphe Street, Building 1300, Durham, NC, 27712

    Description

    VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101

    Reason

    Product's decrease in sensitivity may result in false negative results

    Action

    On August 6, 2003, Biomerieux''s recall letter and customer response form was sent to all US Customers and Biomerieux Global Customer Service in France, who is responsible for notification to all non-US bioMerieux subsidiaries. Non-US subsidiaries/distributors are responsible for notifying non-US Customers. VIDAS Chlamydia (CHL) Assay (product number 30 101) with Lot numbers 040212-0 and 040218-0 will be destroyed in the field.

    Distribution

    Nationwide NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL, WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI International: Japan, Argentina, Brazil, Chile, China, Columbia, Korea, Mexico, Canada, SA

    Quantity

    2204