Events

Recall of ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. 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-2016-RN-00712-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00712-1
  • 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
    Investigations by roche have confirmed an increase in native patient sample result recovery of approximately 15 – 20% when using certain lot combinations of online tdm gentamicin with preciset tdm i calibrator. a combination with tdm control set lot 125783 does not show this effect. this may result in sub therapeutic serum levels of gentamicin leading to a delay in treatment and potentially leading to the spread of infections.
  • Action
    Roche is advising users to immediately stop using ONLINE TDM Gentamicin reagent until further notice. Stock does not need to be discarded at this time. Users may continue to use the Preciset TDM I Calibrator for all other TDM assays on cobas c modules and MODULAR ANALYTICS (except for GENT2) and for all TDM (including GENTM) on COBAS INTEGRA systems. This action has been closed-out on 15/02/2017.

Device

ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device ...
  • Model / Serial
    ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device (IVD)ONLINE TDM Gentamicin, 100 testsMaterial Number: 04490843190Lot Numbers: 119166, 611780, 617623ONLINE TDM Gentamicin, 100 testsMaterial Number: 05841291190Lot Numbers: 119167, 611783, 617624Preciset TDM I CalibratorMaterial Number: 03375790190Lot Numbers: 615118, 619681, 126387, 140735ARTG Number: 174910
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited