Recall of Liquid Assayed Multiqual Premium (multi analyte control material). An in vitro diagnostic medical device (IVD)

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-2012-RN-01101-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-10-30
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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 fructosamine does not meet the stability and performance claims stated in the package insert.
  • Action
    Bio-Rad is providing updated package insert for the affected lots which now indicates that there are no stability or performance claims for Fructosamine.

Device

  • Model / Serial
    Liquid Assayed Multiqual Premium (multi analyte control material). An in vitro diagnostic medical device (IVD)Master lot number 15900Level 1 lot number: 15901; Catalogue number: 284Level 2 lot number: 15902; Catalogue number: 285Level 3 lot number: 15903; Catalogue number: 286Trilevel MiniPak lot number: 15900; Catalogue number: 285X
  • Manufacturer

Manufacturer