BEUDAMED
    FDA Recall Terminated

    10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not for drug, food or household use. Do not Transfer to an unmarked container. Catalog numbers: SF100-4, SF100-20 Fisher Scientific, Fail Lawn, NJ 07410

    Recall: Z-2159-2008 · Initiated May 1, 2008

    Recall

    Recall Number
    Z-2159-2008
    Event Number
    48601
    Firm
    ThermoFisher Scientific Co., LLC
    FEI Number
    2214740
    Product Code
    IFP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 1, 2008
    Posted
    August 25, 2008
    Terminated
    August 13, 2012
    Address
    1 Reagent Ln, Fair Lawn, NJ, 07410-2802

    Description

    10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not for drug, food or household use. Do not Transfer to an unmarked container. Catalog numbers: SF100-4, SF100-20 Fisher Scientific, Fail Lawn, NJ 07410

    Reason

    Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%.

    Action

    Urgent: Product Recall notification letters were sent by US mail on May 1, 2008. The letters asked that those in receipt of the product check their stock for this product, destroy any of the material that remains from the referenced lot, and then contact their local customer service center for a replacement. The letter also states that the appropriate corrective measures have already been instituted to prevent a recurrence.

    Distribution

    Worldwide Distribution --- including USA and Canada.

    Quantity

    1052 x 4 liters, 564 x 20 liters