Z-0168-2014Class II

COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692...

Name: Z-0168-2014 COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692...
Creator: Roche Diagnostics Operations, Inc.
Published: 2013-09-16
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2013-09-16 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer... on 2013-09-16. FDA classified it as Class II and gives the reason as "Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service...". 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-0168-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-16
Posted: 2013-11-05
Terminated: 2015-05-12
Recalling firm: Roche Diagnostics GmbH
Product: COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof
Root cause tag: software
FDA root cause: Software Design Change
Action: Roche sent an Urgent Medical Device Correction letter dated September 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Diagnostics recommends tracking all ISE counters and manually requesting the corresponding Service Actions listed in the notification be monitored until updated software becomes available during Q4 2013. If the affected product was moved to another site, the notification is to be forwarded. consignees were asked to complete the attached faxback form and fax it to 1-877-266-0997 and file the Urgent Medical Device Correction (UMDC) for future reference. Question should be directed to Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 For questions regarding thisr ecall call 317-576-3911.
Quantity in commerce: 527 units
Distribution: Nationwide Distribution and Puerto Rico
Product codes and lots: software version 9864.C2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0168-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0168-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)