Devices

cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic medical device (IVD))

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
1 Event
- Recall of cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic medical device (IVD))

Manufacturer

Roche Diagnostics Australia Pty Limited

Manufacturer Parent Company (2017)
Roche Holding AG
Source
DHTGA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)