BEUDAMED
    FDA Recall Terminated

    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

    Recall: Z-2431-2015 · Initiated July 27, 2015

    Recall

    Recall Number
    Z-2431-2015
    Event Number
    71841
    Firm
    Cepheid
    FEI Number
    3004530258
    Product Code
    LSL
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    July 27, 2015
    Posted
    August 20, 2015
    Terminated
    September 28, 2015
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189

    Description

    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

    Reason

    Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.

    Action

    Notification letters dated July 28 and 29th to all affected customers via Federal Express..

    Distribution

    Worldwide distribution. US nationwide, including North Mariana Islands, Aruba, Canada, Chile, Colombia, Costa Rica, Cyprus, Guam, Guatemala, Italy, Malawi, Micronesia Federated States, Panama, San Marino, South Africa, Spain, Switzerland, and Zimbabwe.

    Quantity

    729 kits US, 47 kits ROW.