Events

Recall of Liquichek Specialty Immunoassay Controls. 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-2016-RN-00146-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00146-1
  • 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 intact pth may not meet the thawed unopened and thawed open vial stability claims as printed in the package inserts. there is a possibility that intact pth values in the lots affected may gradually shift down due to a decrease in stability when the product is stored at 2 to 8°c. the claims for intact pth have been revised from 23 days to 7 days.Although unlikely, the reported issue may result in a delay in result reporting or the false signalling of an in-control situation.
  • Action
    Bio-Rad is advising users not to use the control for intact PTH beyond 7 days when stored at 2 to 8°C. Users are able to obtain a revised package insert with the updated stability time frames from http://myeinsters.qcnet.com

Device

Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)Master Lot Numbers:57430, 57440, 57450, 57460, 57470, 57480, and 57490ARTG Number: 194959
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd