Events

Recall of Sample Probe Connector used with cobas modules. 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 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-00398-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00398-1
  • 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
    Roche has identified that in very rare cases, a disturbance of the sample liquid level detection (lld) may occur due to a fretting corrosion on the sample probe connector. in such instances, the affected sample probe may not aspirate the sample material at the correct level; accordingly the probe may not be washed adequately, resulting in the possibility of sample carryover.This issue, which was detected during an internal investigation, was caused by a production change in the sample probe connector type, potentially causing fretting corrosion on the sample probe connector. to date, roche have not received any complaints about this issue.
  • Action
    Roche is requesting that customers check the sample probe in use in their analyser to determine if the sample probe is from the potentially affected serial/lot numbers. If so, customers are advised to contact Roche to discuss an exchange. Until the sample probe is exchanged, users are requested to follow the detailed instructions provided in the customer letter.

Device

Sample Probe Connector used with cobas modules. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Sample Probe Connector used with cobas modules. An in vitro diagnostic medical device (IVD)Probe SampleMaterial Number: 04547241001Systems affected: cobas c 501/502/701/702 modulesSample ProbeMaterial Number: 04945794001Systems affected: cobas 8000 ISE module 1800Multiple Serial NumbersARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited