BEUDAMED
    FDA Recall Terminated

    Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay

    Recall: Z-0770-04 · Initiated February 23, 2004

    Recall

    Recall Number
    Z-0770-04
    Event Number
    28473
    Firm
    Genzyme Diagnostics
    FEI Number
    1000520007
    Product Code
    MHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 23, 2004
    Posted
    July 20, 2004
    Terminated
    September 15, 2004
    Address
    6659 Top Gun St, San Diego, CA, 92121-4113

    Description

    Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay

    Reason

    False Positive results.

    Action

    Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.

    Distribution

    Product was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD.

    Quantity

    2671 kits