BEUDAMED
    FDA Recall Terminated

    Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.

    Recall: Z-1039-04 · Initiated May 28, 2004

    Recall

    Recall Number
    Z-1039-04
    Event Number
    29292
    Firm
    Digene Corp
    FEI Number
    3003572099
    Product Code
    LSO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 28, 2004
    Posted
    July 20, 2004
    Terminated
    November 23, 2004
    Address
    1201 Clopper Rd, Gaithersburg, MD, 20878-4000

    Description

    Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.

    Reason

    In vitro diagnostic test kit may produce false negative clinical results.

    Action

    The recalling firm notified consignees by phone 5/28/04 and by faxed letter 6/2/04. The letter advised of possible false negative test results and that such results should be retested immediately with replacement kits provided by the firm. The notification further advised that positive results should be considered valid if the assay meets all verification and calibration criteria. Consignees were requested to return product and response form.

    Distribution

    Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom.

    Quantity

    206 kits