Recall of Alfa Wassermann System Diluent 750 mL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alfa Wassermann, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63866
  • Event Risk Class
    Class 2
  • Event Number
    Z-0743-2013
  • Event Initiated Date
    2012-10-10
  • Event Date Posted
    2013-01-28
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-10-25
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
  • 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.

Device

  • Model / Serial
    Lot Number 155599
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
  • Product 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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Alfa Wassermann, Inc., 4 Henderson Dr, W Caldwell NJ 07006-6608
  • Manufacturer Parent Company (2017)
  • Source
    USFDA