Events

Recall of cobas p 512 pre-analytical system. An in vitro diagnostic 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-00189-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00189-1
  • 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
    There have been reports overseas that sample tubes may not be correctly placed back in the rack tube transport (rtt) after the de-capping process. this may result in open tubes being dropped within the cobas p 512 pre-analytical system, contaminating the system and potentially other samples. a false triggering or detection of the “ready” signal from the lifting gripper in the decapper causes the system to register that the motor motion is finished. the system then continues with the next process step and opens the gripper prematurely. this issue may lead to contamination of the instrument and other samples. the risk to operator of contamination is less than remote. however, the contamination of other samples may lead to erroneous sample results with possible inappropriate diagnosis/treatment.
  • Action
    Roche Diagnostics has developed a software patch (71829_p512) to correct the reported issue. The implementation of this software patch is mandatory and will be installed by a Roche Diagnostics Australia field service representative. Users are advised to monitor the system for the Error 140 “Missing Tube” until the software patch is installed. If this error code occurs, please clean all components in contact with the spillage (refer to Operator’s Manual v1.5). This action has been closed-out on 15/02/2017.

Device

cobas p 512 pre-analytical system. An in vitro diagnostic device (IVD)
  • Model / Serial
    cobas p 512 pre-analytical system. An in vitro diagnostic device (IVD)Material Number. 05083435001Serial Number. 4741745 or lowerARTG Number: 212706
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited