Z-0696-2013Class III

Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer

Name: Z-0696-2013 Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer
Creator: Roche Diagnostics Operations, Inc.
Published: 2012-11-19
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2012-11-19 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer on 2012-11-19. FDA classified it as Class III and gives the reason as "A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an...". 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-0696-2013
Classification: Class III
Status: Terminated
Initiated: 2012-11-19
Posted: 2013-01-18
Terminated: 2014-01-13
Recalling firm: Roche Diagnostics GmbH
Product: Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access
Root cause tag: software
FDA root cause: Software design
Action: Roche sent an Urgent Medical Device Correction letter on November 19, 2012, to all affected customers via UPS Ground (receipt required). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached form and return by fax and file this Medical Device Correction for future reference. For technical support customers were instructed to contact Diagnostics Technical Support at 1-900-428-2336. For questions regarding this recall call 317-521-3911.
Quantity in commerce: 845 Units
Distribution: Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR.
Product codes and lots: Part Numbers: 28065047001 and 03245233001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0696-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0696-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-18

Product code JJE

K951595Class IIRoche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. / cleared 1995-09-08

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)