BEUDAMED
    FDA Enforcement Class II Terminated

    Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.

    Recall: Z-0806-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0806-2013
    Event ID
    63558
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    August 20, 2012
    Classification Date
    February 12, 2013
    Termination Date
    June 4, 2013
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    Description

    Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.

    Reason

    The firm is recalling the products due to a potential for false negative test results.

    Code Info

    Lots: 082505; 131988; 131994

    Distribution

    Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom

    Quantity

    493 of lot 082505; 529 of lot 131988; and 448 of lot 131994