Z-0489-2013Class II

The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access...

Name: Z-0489-2013 The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access...
Creator: Roche Molecular Systems, Inc.
Published: 2012-07-16
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2012-07-16 / Terminated / root cause: software

FDA source

Roche Molecular Systems, Inc. began a recall of The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and... on 2012-07-16. FDA classified it as Class II and gives the reason as "Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0489-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-16
Posted: 2012-12-07
Terminated: 2015-07-22
Recalling firm: Roche Molecular Systems Inc
Product: The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
Product code: NSX
Reason for recall: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Root cause tag: software
FDA root cause: Software design
Action: Roche sent an "Urgent Medical Device Correction" (UMDC) notification letter dated July 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Molecular Systems, Inc. has disabled this software on affected Roche platforms and discontinued the distribution of the affected software. Contact Roche Diagnostic Technical Support, 24 hours a day, seven days a week at phone number : 1-800-428-2336 if you have questions regarding this notification. For questions regarding this recall call 908-253-7569.
Quantity in commerce: 77 units
Distribution: Nationwide Distribution
Product codes and lots: Device-associated diagnostic software

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0489-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0484-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0485-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0486-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0487-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0488-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0489-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0490-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0491-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0492-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0493-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07

Product code NSX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)