Events

Recall of ONLINE TDM Gentamicin. An in vitro diagnostic medical device (IVD)cobas c 501/502 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-00374-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00374-1
  • 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
    On 30 may 2016, customers using the online tdm gentamicin (gent2) assays were advised to stop using certain lots of the assay due to reports of increased recovery in patient results. (customers would also have received the customer bulletin reference number: cc16-029, notifying that the online tdm gentamicin assay was once again available for use following the implementation of a mandatory instrument factor (a = 0.8) and re-assignment of the tdm control set values.)several reports have since been received that after the instrument factor (if) was implemented, decreased recovery of patient results were observed. further internal investigations suggested that the if of 0.8 is incorrect, leading to decreased recovery of gentamicin results. this may lead to over dosage, which would cause potential toxic concentrations in patients.
  • Action
    Roche Diagnostics Australia (Roche) is requesting users NOT to implement the IF of 0.8 on cobas c 501/502/701/702 modules. Users are further requested to reset or leave the IF at1.0 and set the technical limit back to the original values. Roche has released re-assigned control values (which have to be implemented) via updated e-packages and would like to advise users that work a on a long term solution to correct the issue is still underway. Users are requested to follow further instructions as detailed in their recall notification letter.

Device

ONLINE TDM Gentamicin. An in vitro diagnostic medical device (IVD)cobas c 501/502 modules
  • Model / Serial
    ONLINE TDM Gentamicin. An in vitro diagnostic medical device (IVD)cobas c 501/502 modulesMaterial Number: 04490843190cobas c 701/702 modulesMaterial Number: 05841291190ARTG Number: 174910
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited