BEUDAMED
    FDA Recall Terminated

    RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).

    Recall: Z-1546-2012 · Initiated March 29, 2012

    Recall

    Recall Number
    Z-1546-2012
    Event Number
    61500
    Firm
    Thera Test Laboratories, Inc.
    FEI Number
    1421346
    Product Code
    DHR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 29, 2012
    Posted
    May 14, 2012
    Terminated
    September 5, 2017
    Address
    1111 N Main St, Lombard, IL, 60148-1360

    Description

    RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).

    Reason

    The RF IgA Calibrator component of the EL-RF/3 Rheumatoid Factor test system may be unstable, resulting in a drop in the RF IgA calibrator OD value which could invalidate an RF IgA test run.

    Action

    TheraTest sent "Urgent Device Recall" letters dated March 28, 2012 to customers that received the affected kit, requesting them to return or destroy the remainder of the product. TheraTest issued a replacement kit to all customers that had unused product as well as any material they consumed which resulted in a failed run. Customers were also instructed to complete the enclosed confirmation form and fax the completed form back to TheraTest. Any questions were directed to TheraTest at 800-441-0771.

    Distribution

    Nationwide Distribution (US)

    Quantity

    207 kits