BEUDAMED
    FDA Recall Terminated

    Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, Minato-ku, Tokyo, Japan. Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-thalassemia testing on the Tosoh G7.

    Recall: Z-3030-2011 · Initiated May 25, 2011

    Recall

    Recall Number
    Z-3030-2011
    Event Number
    59488
    Firm
    Tosoh Bioscience Inc
    FEI Number
    3005529799
    Product Code
    JPD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 25, 2011
    Posted
    August 17, 2011
    Terminated
    February 24, 2012
    Address
    3600 Gantz Road Grove, City, OH, 43123

    Description

    Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, Minato-ku, Tokyo, Japan. Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-thalassemia testing on the Tosoh G7.

    Reason

    The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%.

    Action

    TOSOH Bioscience sent an "Urgent Recall Notification" letter dated July, 25, 2011 to all affected customers. The letter described the problem and asks customers to immediately discontinue use of the product and return all remaining product back to the firm. Customers can contact TOSOH for replacement. For additional information or question on this recall please contact TOSOH Technical Support at (800) 248-6769.

    Distribution

    Worldwide Distribution: Nationwide (USA) distribution including the states of FL and IL; and the country of Canada.

    Quantity

    6 boxes/4/2 mL btls