BEUDAMED
    FDA Recall Terminated

    IMx HAVAB Controls In Vitro Test

    Recall: Z-0660-05 · Initiated March 4, 2005

    Recall

    Recall Number
    Z-0660-05
    Event Number
    31342
    Firm
    Abbott Health Products, Inc.
    FEI Number
    2623532
    Product Code
    LOL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2005
    Posted
    March 29, 2005
    Terminated
    September 29, 2005
    Address
    Hwy 2 Km 58.0, Barceloneta, PR, 00617

    Description

    IMx HAVAB Controls In Vitro Test

    Reason

    Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.

    Action

    Abbott identified through investigational studies that IMx HAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package insert. If a control value is out of the specified range, the assay run is invalid and assay recalibration may be indicated. If the control values are within range as specified in the package insert, the assay run is valid and the patient results are not impacted.

    Distribution

    The recalled IMx HAVAB Controls were distributed nationwide in the United Stated, including Puerto Rico and internationally were distributed to Canada, Peru, Germany, Japan, Australia, and Singapore. There are US Government accounts.

    Quantity

    373 Kits