BEUDAMED
    FDA Recall Terminated

    Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.

    Recall: Z-0676-06 · Initiated January 26, 2006

    Recall

    Recall Number
    Z-0676-06
    Event Number
    34687
    Firm
    Alfa Wassermann, Inc
    FEI Number
    1000122044
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2006
    Posted
    March 23, 2006
    Terminated
    April 18, 2006
    Address
    4 Henderson Dr, West Caldwell, NJ, 07006-6608

    Description

    Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.

    Reason

    Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.

    Action

    Field correction letters were sent to the firm's customers via FAX on 1/14/2006-1/17/2006 and via UPS on 1/17/2006-1/19/2006. An updated letter was sent out via FAX on 1/27,30,31/2006 and via UPS on 1/30/2006 and 2/1/2006.

    Distribution

    The kits were sent nationwide. The product was shipped to Alfa Wasserman's sister firm in Wergen, Netherlands. There are several US Navy accounts.

    Quantity

    22,987 kits