BEUDAMED
    FDA Recall Terminated

    Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.

    Recall: Z-1438-2011 · Initiated December 30, 2008

    Recall

    Recall Number
    Z-1438-2011
    Event Number
    55432
    Firm
    Gen-Probe Inc
    FEI Number
    2024800
    Product Code
    LQF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 30, 2008
    Posted
    March 10, 2011
    Terminated
    June 8, 2011
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121

    Description

    Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.

    Reason

    This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.

    Action

    Gen-Probe issued a Recall Notice to customers recommending that they discontinue the use of the identified batch (lot) numbers listed. For customers that have used these batches and obtained negative results, they recommend that the referring physician be notified about the possibility of a false negative result. With the Recall Notice, consignees received a Customer Response Form to complete. Gen-Probe requested that they segregate the affected batches listed on the Customer Response Form, then reconcile, and destroy all partial and/or full kits left in inventory, being sure to document the amount destroyed on the Customer Response Form. Gen-Probe should be updated via phone, fax, and email information. Customers should then sign and return the completed form to Gen-Probe via fax to 858-410-8250, or scanned and emailed to [email protected]. The Technical Support team should be contacted for replacement kits. Technical Support was also available for additional information at 888-484-4747 or [email protected].

    Distribution

    Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.

    Quantity

    1293 kits