BEUDAMED
    FDA Enforcement Class II Terminated

    Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.

    Recall: Z-0592-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0592-2018
    Event ID
    78910
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cepheid
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    October 9, 2017
    Classification Date
    February 12, 2018
    Termination Date
    February 13, 2018
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189, United States

    Description

    Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.

    Reason

    Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.

    Code Info

    Lot numbers: 25718, 25719, 25725, and 25727.

    Distribution

    Worldwide Distribution -- USA, Puerto Rico, and Haiti.

    Quantity

    3,586 kits (49,400 units)