BEUDAMED
    FDA Enforcement Class II 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 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-1022-2013
    Event ID
    64501
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Genetic Testing Institute,inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    February 4, 2013
    Classification Date
    March 28, 2013
    Termination Date
    March 21, 2016
    Address
    20925 Crossroads Cir Ste 200, Waukesha, WI, 53186-4054, United States

    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

    Code Info

    Kit Lot Number 3000389

    Distribution

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

    Quantity

    386 kits (370 US, 16 OUS)