BEUDAMED
    FDA Recall Terminated

    Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of Heparin Adsorbent, 10 tubes per foil lined pouch, 10 foil pouches/box, Inotech Biosystems International, Inc., Rockville, MD 20855

    Recall: Z-0934-2008 · Initiated August 20, 2007

    Recall

    Recall Number
    Z-0934-2008
    Event Number
    45407
    Firm
    Inotech Biosystems Intl., Inc
    FEI Number
    1832416
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    August 20, 2007
    Posted
    February 7, 2008
    Terminated
    August 7, 2012
    Address
    15713 Crabbs Branch Way, Ste 110, Rockville, MD, 20855-2607

    Description

    Inotech brand Heparin Adsorbant, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of Heparin Adsorbent, 10 tubes per foil lined pouch, 10 foil pouches/box, Inotech Biosystems International, Inc., Rockville, MD 20855

    Reason

    Erroneous Coagulation Tests

    Action

    The recalling firm notified consignees by phone on 08/20/07 and provided instructions for increasing the speed of centrifugation from 1,500 x g to 2,500 x g and decanting the supernatant aliquot carefully so as to not draw in resin fibers that may be stuck on the test tube walls during sample preparation for testing in the coagulation studies. The firm updated their recall notification on 10/01/07 as an Urgent Recall/Correction to alert healthcare practitioners to not use "lupus sensitive reagents" with the heparin absorbant product and that Platelet Factor 3 and any other negatively charged molecule in the plasma may interact with the resin causing false high readings due to the partial removal of the clotting initiating factors.

    Distribution

    Worldwide; USA to Hospitals and Clinical Laboratories and to one domestic distributor for export to Canada.

    Quantity

    37,370 tubes