Events

Recall of cobas p 612 pre-analytical system (LCP1). 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-2018-RN-00945-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-07-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00945-1
  • 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
    During internal investigations, roche diagnostics confirmed that in rare cases, sample material may come in contact with the pipetting nozzle during operation of the cobas p 612 pre-analytical system. this may lead to contamination of samples and, if a highly sensitive analytical technology is used e.G. molecular testing, inaccurate results may be produced.Cobas p 612 pre-analytical systems that use disposable filter tips are not affected by this issue.Roche has received no complaints worldwide for this issue; none from australian customers to date.
  • Action
    Roche Diagnostics Australia is advising that the use of disposable filter tips in the cobas p 612 pre-analytical system will be mandatory until the root cause is identified and appropriate corrective actions have been implemented. Roche Diagnostics Australia will contact laboratories in due course to arrange the modifications required for using disposable filter tips. The root cause investigation is still ongoing. Roche will send an update as soon as the root cause is identified and corrective measures are available.

Device

cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD).
  • Model / Serial
    cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD).Affected part: ADP NozzleMaterial Number: 07563116001ARTG Number: 212706(Roche Diagnostics Australia Pty Limited - Instrument/analyser IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited