BEUDAMED
    FDA Recall Terminated

    Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.

    Recall: Z-0873-03 · Initiated April 21, 2003

    Recall

    Recall Number
    Z-0873-03
    Event Number
    26195
    Firm
    Dade Behring Inc Rte 896, Glasgow Business Community
    FEI Number
    2517506
    Product Code
    LTJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 21, 2003
    Posted
    May 29, 2003
    Terminated
    July 31, 2003
    Address
    Newark, DE, 19702

    Description

    Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.

    Reason

    test results may be inaccurate by 0.2 to 0.5 ng/mL

    Action

    The recalling firm telephone each customer on 4/24-28/03 to determine if any customer used the lot (CD4085). If so, the customer was instructed to retest all samples with an alternate lot. All customers were instructed to discard any remaining inventory. As a follow up to the phone calls, the recalling firm issued a recall letter dated 4/25/03 informing the customer of the problem and to discard any remaining product.

    Distribution

    The product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign.

    Quantity

    662 cartons