BEUDAMED
    FDA Recall Terminated

    Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal specimens.

    Recall: Z-2432-2008 · Initiated August 11, 2008

    Recall

    Recall Number
    Z-2432-2008
    Event Number
    49090
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    MHI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 11, 2008
    Posted
    September 19, 2008
    Terminated
    January 21, 2010
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal specimens.

    Reason

    Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive

    Action

    The recalling firm issued letters dated 6/19/08 flagged "IMPORTANT PRODUCT INFORMATION" which advised their customers of the issue with the faint grey test lines but did not request any action be taken, such as return or destruction of the affected lot numbers. The recalling firm issued a second letter flagged "IMPORTANT MEDICAL DEVICE CUSTOMER ADVISORY NOTICE" dated 8/11/08 and was issued via regular mail on 8/14/08. This letter asked users to review their inventory for the product lots indicated in the letter, discard all remaining units of this product lot, complete and return the Product Inventory Checklist regardless if they have affected product. A "PRODUCT INVENTORY CHECKLIST" was enclosed to report whether the firm had product to discard and the amount to be replaced.

    Distribution

    Worldwide Distribution --- including USA and countries of Canada and U.K.

    Quantity

    3,974 kits