BEUDAMED
    FDA Recall Terminated

    Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA

    Recall: Z-0244-2008 · Initiated September 28, 2006

    Recall

    Recall Number
    Z-0244-2008
    Event Number
    44894
    Firm
    Applied Biotech Inc
    FEI Number
    1000125390
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 28, 2006
    Posted
    November 21, 2007
    Terminated
    August 3, 2012
    Address
    10237 Flanders Ct, San Diego, CA, 92121-2901

    Description

    Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA

    Reason

    Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.

    Action

    A Product Recall Notification dated 9/28/2006, was provided via fax, email or direct mail to all primary consignees. Customers were instructed to block all stock of affected lots in their warehouses, contact their primary consignees and advise them to discontinue use immediately and dispose of any unused materials; using a fax back form to communicate to the recalling firm the quantity blocked and disposed of so that arrangements could be made for providing replacement product

    Distribution

    Worldwide: USA and Canada

    Quantity

    400 Kits (1,200 tests)