BEUDAMED
    FDA Recall Terminated

    4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

    Recall: Z-0007-2008 · Initiated June 22, 2007

    Recall

    Recall Number
    Z-0007-2008
    Event Number
    38494
    Firm
    Tosoh Bioscience Inc
    FEI Number
    3005529799
    Product Code
    JJX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 22, 2007
    Posted
    October 3, 2007
    Terminated
    October 7, 2010
    Address
    3600 Gantz Road Grove, City, OH, 43123

    Description

    4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

    Reason

    Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was measured. Tosoh AIA confirmed that deterioration of the product occurred over time and resulted in a deviation from the assigned value.

    Action

    Letter, dated July 2, 2006. Immediately examine inventory and quarantine product. If product was further distributed, the direct accounts are to notify their customers including a copy of the original recall letter and Notification of Recall response card.

    Distribution

    Nationwide.

    Quantity

    47 Boxes