BEUDAMED
    FDA Recall Terminated

    Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.

    Recall: Z-0743-2013 · Initiated October 10, 2012

    Recall

    Recall Number
    Z-0743-2013
    Event Number
    63866
    Firm
    Alfa Wassermann, Inc.
    FEI Number
    1000122044
    Product Code
    CEO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 10, 2012
    Posted
    January 28, 2013
    Terminated
    October 25, 2013
    Address
    4 Henderson Dr W, Caldwell, NJ, 07006-6608

    Description

    Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.

    Reason

    Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

    Action

    Alfa Wassermann sent an important advisory notice/product response form to their distributors on October 10, 2012. The letter identified the product, the problem, and the action to be taken by the customer. The letter informs customers about the affected lot and provide instruction regarding the receipt of replacement product. Any recalled product should be destroyed. If there is further distribution, those customers should provide Alfa with a distribution list so that they may be notified. Any questions can be directed to (866) 419 - 2532.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands

    Quantity

    4,104 kits