Events

Recall of Pipet Tips used with AutoDG System. An in vitro diagnostic medical device

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-01481-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-12-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01481-1
  • 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
    This failure appears as low total volume in the well of the autodg droplet plate after automated droplet generation, and results in low droplet counts when analyzing data in quantasoft. the failure is most frequently observed in columns 2 and 8 of the droplet plate, which corresponds to the fourth column of pipet tips in each box (when loaded with the box label facing front). this issue may impact pipet tip lots listed in the product details table above shipped in 2017and is most frequently observed with pipet tips from column 4 of the pipet tip box. this defect has no safety or efficacy impact, and will not result in erroneous results.
  • Action
    Bio-Rad has decided to continue to ship pipet tips with a short-term workaround detailed in the Customer Letter.

Device

Pipet Tips used with AutoDG System. An in vitro diagnostic medical device
  • Model / Serial
    Pipet Tips used with AutoDG System. An in vitro diagnostic medical deviceProduct Number: 1864120, 1864121, 12003010Lot Numbers: PR136933, PR137957, PR138863, PR139939, PR136556, PR136109, PR134751, PR135656, PR135220ARTG Number: 296086
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd