BEUDAMED
    FDA Recall Terminated

    Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100

    Recall: Z-0304-06 · Initiated September 23, 2005

    Recall

    Recall Number
    Z-0304-06
    Event Number
    33800
    Firm
    Dade Behring Inc.
    FEI Number
    2517506
    Product Code
    GGW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 23, 2005
    Posted
    December 23, 2005
    Terminated
    May 11, 2006
    Address
    500 GBC Dr. PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100

    Reason

    prolonged aPTT results

    Action

    The recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product.

    Distribution

    The products were shipped to medical facilities and/or laboratories nationwide.

    Quantity

    4176 packs