BEUDAMED
    FDA Enforcement Class II 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 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0743-2013
    Event ID
    63866
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alfa Wassermann, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    October 10, 2012
    Classification Date
    January 28, 2013
    Termination Date
    October 25, 2013
    Address
    4 Henderson Dr, W Caldwell, NJ, 07006-6608, United States

    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.

    Code Info

    Lot Number 155599

    Distribution

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

    Quantity

    4,104 kits