BEUDAMED
    FDA Recall Terminated

    Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).

    Recall: Z-1022-2013 · Initiated February 4, 2013

    Recall

    Recall Number
    Z-1022-2013
    Event Number
    64501
    Firm
    Genetic Testing Institute, inc
    FEI Number
    2183608
    Product Code
    LCO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 4, 2013
    Posted
    March 28, 2013
    Terminated
    March 21, 2016
    Address
    20925 Crossroads Cir, Ste 200, Waukesha, WI, 53186-4054

    Description

    Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).

    Reason

    Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati

    Action

    Hologic/Gen-Probe sent an Urgent Medical Device Recall letter dated February 4, 2013, via FedEx overnight deliver yto all affected customers. The letter identified affected product, stated the issue, and asked that product from the affected lot stop being used. Reported results for all samples tested using the affected lot should be reviewed. The referring physician should be notified that any negative patient result may be erroneous. Remaining inventory should be returned to Gen-Probe. A response form was also asked to be returned. For questions customers were instructed to contact Technical Support at 262-754-1000 or [email protected]. For questions regarding this recall call 262-754-1026.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.

    Quantity

    386 kits (370 US, 16 OUS)