BEUDAMED
    FDA Recall Terminated

    Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product 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-0807-2013 · Initiated August 20, 2012

    Recall

    Recall Number
    Z-0807-2013
    Event Number
    63558
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    LLH
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 20, 2012
    Posted
    February 12, 2013
    Terminated
    June 4, 2013
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product 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.

    Action

    Thermo Fisher sent a recall notification letter with details of the recall on August 20, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were requested to follow the instructions provided and fax back the attached "Acknowledgement & Receipt Form" to 1-877-428-1924 (toll free in the US) or 1-913-895-4190 (International). For questions contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

    Distribution

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

    Quantity

    50 units