BEUDAMED
    FDA Recall Terminated

    Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.

    Recall: Z-0655-03 · Initiated February 7, 2003

    Recall

    Recall Number
    Z-0655-03
    Event Number
    25678
    Firm
    Digene Corp
    FEI Number
    3003572099
    Product Code
    MAQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 7, 2003
    Posted
    March 19, 2003
    Terminated
    July 16, 2003
    Address
    1201 Clopper Road, Gaithersburg, MD, 20878

    Description

    Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.

    Reason

    In Vitro diagnostic test kit may produce false positive patient results

    Action

    The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.

    Distribution

    Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.

    Quantity

    848 kits/ 96 assays per kit