Events

Recall of qUAntify Control / qUAntify Plus Control. 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-2018-RN-00732-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-06-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00732-1
  • 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 have observed that the values for blood and ketones may gradually decrease, and values for ph may gradually increase over the shelf life of affected product lots. this issue is not expected to impact patient results.
  • Action
    Bio-Rad is advising users that the package insert has been updated to specify the changing values for these analytes. Laboratory means and acceptable ranges may need to be re-established for Blood, Ketones and pH during the shelf life of the product.

Device

qUAntify Control / qUAntify Plus Control. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    qUAntify Control / qUAntify Plus Control. An in vitro diagnostic medical device (IVD). Catalogue Numbers: 975, 975X, 995, 995X (12 mL), 962, 963, 964, 962X (120 mL)Lot Numbers: 78770, 78780, 80510, 80520, 80530, 80540, 80550, 80560, 79610, 79620, 79630, 79640, 79650, 79660ARTG Number: 206309Bio-Rad Laboratories - Clinical chemistry biological screening IVDs
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd