BEUDAMED
    FDA Recall Terminated

    Device to determine quantitative total testosterone in human serum

    Recall: Z-0090-04 · Initiated September 19, 2003

    Recall

    Recall Number
    Z-0090-04
    Event Number
    27562
    Firm
    Qualigen Inc
    FEI Number
    3003355251
    Product Code
    CDZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 19, 2003
    Posted
    November 6, 2003
    Terminated
    March 30, 2004
    Address
    2042 Corte Del Nogal, Carlsbad, CA, 92009-1438

    Description

    Device to determine quantitative total testosterone in human serum

    Reason

    Kits may produce results that are falsely elevated.

    Action

    All customers who received any one of the three lots have been faxed a removal letter starting 09/24/03. Certified or Airborne letter sent on 09/29/03.

    Distribution

    Nationwide and Switzerland.

    Quantity

    81 Kits