BEUDAMED
    FDA Recall Terminated

    Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089

    Recall: Z-0376-2008 · Initiated September 5, 2007

    Recall

    Recall Number
    Z-0376-2008
    Event Number
    45494
    Firm
    Cepheid
    FEI Number
    3004530258
    Product Code
    NJR
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    September 5, 2007
    Posted
    January 12, 2008
    Terminated
    April 4, 2008
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189

    Description

    Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089

    Reason

    Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file)

    Action

    Consignees were sent a Correction and Removal letter on 09/04/2007, notifying them that there was a labeling error with some of the cartridges labels indicating Xpert EV instead of Xpert GBS on the cartridge label. They are asked to discontinue using it immediately and return to Cepheid.

    Distribution

    Worldwide Distribution

    Quantity

    105