Events

Recall of Ultrasonic Mixer cover (USM) 3. An in vitro diagnostic medical device (IVD)(used with cobas c 501 and c502 modules)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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-00902-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00902-1
  • 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
    When the incubation bath is cleaned or cuvettes replaced on the cobas c 501/502 modules during routine monthly maintenance, the usm cover 3 is removed. whilst loosening one of the thumb screws on this cover, an instrument operator cut their thumb on the 90-degree edge of the thumb screw bracket.Given the cobas c 501 modules and cobas c 502 modules share the same hardware, roche diagnostics has, as a precaution, decided to inform and request operators of both systems to perform the related maintenance task with special caution, to prevent any further occurrence.Although the design of the usm cover 3 is according to the manufacturer’s specification, and the 90-degree edge is clearly visible, a medical risk due to an injury cannot be entirely excluded. roche has received only one complaint since this product was launched in 2006. a warning statement will be added to the respective operator manuals specifying the need to perform the related maintenance task with special caution.
  • Action
    Roche Diagnostics will add a warning statement to the respective operator manuals, which will be available by December 2017.

Device

Ultrasonic Mixer cover (USM) 3. An in vitro diagnostic medical device (IVD)(used with cobas c 501...
  • Model / Serial
    Ultrasonic Mixer cover (USM) 3. An in vitro diagnostic medical device (IVD)(used with cobas c 501 and c502 modules)Material Number: 05400937001ARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited