BEUDAMED
    FDA Recall Terminated

    Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.

    Recall: Z-0014-05 · Initiated April 6, 2004

    Recall

    Recall Number
    Z-0014-05
    Event Number
    29984
    Firm
    Zymed Laboratories Inc.
    FEI Number
    3000203719
    Product Code
    MXZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 6, 2004
    Posted
    October 9, 2004
    Terminated
    October 29, 2004
    Address
    561 Eccles Ave, South San Francisco, CA, 94080-1906

    Description

    Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.

    Reason

    Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.

    Action

    The firm has conducted telephone calls and visits to its consignees, with confirmation done by phone and fax. The firm has recovered or accounted for 100% of the products, either returned or destroyed.

    Distribution

    The Firm distributed to a total of 8 domestic consignees and an unspecified number of foreign consignees. The products were distributed to MD, GA, TX, OH, IL, DC, NY and CA. Foreign countries distributed to include France, Portugal, China, Italy, Israel, Philippines, and Germany.

    Quantity

    24 vials of the mouse anti-TTF-1 concentrate have been released in distribution.