BEUDAMED
    FDA Recall Terminated

    Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.

    Recall: Z-0305-2007 · Initiated July 25, 2006

    Recall

    Recall Number
    Z-0305-2007
    Event Number
    36096
    Firm
    EMD Chemicals Inc
    FEI Number
    2244894
    Product Code
    KKS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 25, 2006
    Posted
    December 27, 2006
    Terminated
    October 6, 2008
    Address
    480 S Democrat Rd, Gibbstown, NJ, 08027-1239

    Description

    Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.

    Reason

    Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.

    Action

    On July 27, 2006 EMD contacted its direct account customers via letter. The firm requested discontinue use of the product and contact EMD for return.

    Distribution

    Nationwide.

    Quantity

    74 kits