Events

Recall of Liquichek Diabetes Control

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-2017-RN-00267-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00267-1
  • 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
    Bio-rad has observed that the values for the analyte haemoglobin a1c may gradually decrease over the shelf life of certain product lots.
  • Action
    Bio-Rad advises:- 1. Laboratory means and acceptable ranges may need to be re-established for HbA1C during the shelf life of the product; 2. Users are requested to obtain a revised copy of the Liquichek Diabetes Control package insert through the Internet at http://myeinserts.qcnet.com Discard all previous versions of the package insert for these lots of product that they may have at each location and substitute those with the revised package insert.

Device

Liquichek Diabetes Control
  • Model / Serial
    Liquichek Diabetes ControlMaster Lot Numbers: 38530, 38540, 38530VLevels: 1, 2, 3 and MiniPakCatalogue Numbers: 171, 172, 173, 172X, 291, 292, 293, 292XARTG Number: 198363
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd