Events

Recall of Cobas e 801 Analytical Unit. An in vitro diagnostic medical device.

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-00215-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00215-1
  • 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 an issue with the syringe plunger on the cobas e 801 analytical unit prewash (pw) syringe assembly. this issue may also occur on the instrument’s r1 or r2 reagent syringe assembly. investigations by the manufacturer have determined that depending on the affected syringe, r1, r2 or prewash liquids may not be pipetted correctly.In the worst case scenario during the cobas e 801 analytical unit initialisation steps, the plunger may crack leading to an impaired syringe function. this may affect the pipetting as follows:- if the prewash syringe plunger is broken, the cobas e 801 module cannot detect it and no alarm is issued. in this instance, the prewash step required by most assays will not be performed and an impact on measurement results cannot be excluded.- if the r1 or r2 syringe plunger is broken, a system alarm "345-1 warning abnormal low signal" is generated and data alarm (.
  • Action
    Roche Diagnostics has contacted affected sites and arranged for the installation of a hardware modification kit which ensures correct positioning and movement of the syringe plungers to prevent the issue from occurring.

Device

Cobas e 801 Analytical Unit. An in vitro diagnostic medical device.
  • Model / Serial
    Cobas e 801 Analytical Unit. An in vitro diagnostic medical device.Material Number: 07682913001Serial Numbers: 1601-01 to 18E6-10Affected Part: Plunger (798-3203) ARTG: 173887Roche Diagnostics Australia - Instrument/analyser IVDs
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited