Events

Recall of cobas 8000 modular analyser series. 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-2017-RN-00381-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00381-1
  • 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 have identified incorrect information regarding acceptable non-standard tube (nst) diameter in the operator’s manual for the cobas 8000 modular analyser series. version 5.0 of the operator’s manual for this system (published 1 july 2016) incorrectly states that 11 to 16 mm diameter nsts may be used on the cobas e 602 module and cobas e 801 module. this was found in the chapter “specifications of containers”, section “list of non-standard tubes”.This typographical error has now been corrected in version 5.1 of the manual (published 6 february 2017), to state that only 13 to 16 mm diameter nsts may be used on the cobas e 602 module or cobas e 801 module. version 4.2.1 and all prior versions of the operator’s manual also state the correct acceptable nst diameters. to date, no customer complaints regarding this issue have been received.
  • Action
    Roche is advising users to ensure that only tubes with a diameter of 13 to 16mm are used on the cobas e 602 and cobas e 801 modules. Users are requested to replace any available Version 5.0 cobas 8000 operator’s manual in your laboratory network with Version 5.1, which contains the correct non-standard tube diameter information. This updated version is also available for download.

Device

cobas 8000 modular analyser series. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    cobas 8000 modular analyser series. An in vitro diagnostic medical device (IVD)cobas e 602 moduleMaterial Number: 05990378001cobas e 801 moduleMaterial Number: 07682913001ARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited