Events

Recall of NaCl, Enzyme Test and Cold Agglutinins ID Number: 50520

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bio-Rad Laboratories Pty Ltd.

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
    RC-2014-RN-01000-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01000-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    During an internal investigation, the manufacturer determined that well number 3 of id card nacl, enzyme test and cold agglutinins of the affected lot may contain on a random basis a very small amount of monoclonal anti-e (anti-rh3).
  • Action
    Bio-Rad is advising users to destroy any remaining affected units if unaffected lots of product are available. As an interim measure, if another lot is not immediately available it is possible to use lot 50520.93.09 with particular attention to the interpretation of positive results: - By manual method, do not use well 3 of the card. - On the automated method, if a positive result is obtained in well 3, use the manual method following the instruction above. This action has been closed-out on 03/06/2016.

Device

NaCl, Enzyme Test and Cold Agglutinins ID Number: 50520
  • Model / Serial
    NaCl, Enzyme Test and Cold Agglutinins ID Number: 50520Reference Numbers: 005014 / 005015 / 005016 Batch number : 50520.93.09 with expiry 2016.01ARTG Number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd