Events

Recall of cobas 8000 modular analyser series, control unit software version 03-03 (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-2013-RN-00293-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00293-1
  • 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
    When using the automatic dilution function on cobas e 602, a software bug occurs leading to an incorrect diluent being used during operation on certain elecsys assays. this happens when all three of the following conditions are present concurrently:- a total of > 2000 reagents kits or diluents had been registered on the cobas e 602 modules within one configuration; and- two or more different diluent types are available on board on the instrument (eg. diluent universal and diluent multiassay); and- a previous diluent (eg diluent universal) had been registered in the database with the identical key information has the current diluent of a different type (eg diluent multiassay).
  • Action
    Roche is providing work around instructions and a software correction is being developed.

Device

cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic m...
  • Model / Serial
    cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic medical device (IVD)) Affected Elecsys assays and their catalogue numbers:CA 15-3 II (03045838122)CMV IgM (04784618190)Anti-HAV IgM (11820591122)Anti-HBc IgM (11820567122)Rubella IgM (04618831190)Toxo IgM (04618858190)CMV IgG Avidity (05909708190)Cortisol (11875116122)Estradiol II (03000079190)N-MID Osteocalcin (12149133122)Toxo IgG (04618815190)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited