Events

Recall of D-10 Rack Loader. 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-00099-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00099-1
  • 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
    There is a potential for a sample and result to be mismatched when running in the d-10 rack loader configuration. this means that a patient result may be assigned to an incorrect sample id. while only two instances have been reported, bio-rad wants users to be aware of the possibility.
  • Action
    Bio-Rad is investigating the reported issue and preparing a permanent solution. In the interim, users are advised to not skip positions within the rack. While reviewing results, check the Daily Summary for the following: A. Confirm that the number of results equals the total number of samples run. B. Confirm that injection numbers (I#) within an individual rack (R#) are consecutive. C. Confirm that any sample that was assigned an auto-generated Sample ID is actually missing a barcode label on the sample tube. Bio-Rad Laboratories will release a follow-up communication providing a permanent solution upon completion of a thorough investigation.

Device

D-10 Rack Loader. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    D-10 Rack Loader. An in vitro diagnostic medical device (IVD).Catalogue Number: 220-0600ARTG Number: 212703
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd