Z-1368-2013Class II

Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module...

Name: Z-1368-2013 Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module...
Creator: Roche Diagnostics Operations, Inc.
Published: 2013-04-04
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2013-04-04 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay... on 2013-04-04. FDA classified it as Class II and gives the reason as "When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following...". 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-1368-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Posted: 2013-05-23
Terminated: 2015-02-24
Recalling firm: Roche Diagnostics GmbH
Product: Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluent
Root cause tag: software
FDA root cause: Software design
Action: Roche sent an Urgent Medical Device Correction (UMDC) letter dated April 4, 2013 via UPS to all affected customers. The letter idenified the affected product, problem and instruction to be followed. Customers were instructed to consult with the physician or pathologist at their facility to determine specific clinical implications for patients. A future software version will correct this issue. Customers were asked to complete and fax back the UMDC attached fax form to 1-88-628-0730. Questions should be addresssed to Roche Diagnostics Technical Support 24 hours a day at 1-800-428-2336.
Quantity in commerce: 72 units
Distribution: USA Nationwide Distribution
Product codes and lots: Part Number 05990378001 Serial Numbers 1017-06, 1021-03, 1021-05, 1142-09, 1145-10, 1140-01, 1125-07, 1128-02, 1146-01, 1146-02, 1146-03, 1171-10, 1169-06, 1169-08, 1169-09, 1172-09, 1156-01, 1156-02, 1156-09, 1160-04, 1160-06, 1016-05, 1017-01, 1139-08, 1139-10, 1140-07, 1140-08, 1140-10, 1156-06, 1156-07, 1158-09, 1160-01, 1160-05, 1173-01, 1139-06, 1139-07, 2374-11, 1127-08, 1138-08, 1138-10, 1139-01, 1156-08, 1156-10, 1173-10, 1156-05, 1158-10, 1139-09, 1131-08, 1132-01, 1132-02, 1171-07, 1171-08, 1171-09, 1147-05, 1149-01, 1124-05, 1124-06, 1132-03, 1132-04, 1147-05, 1149-01, 1128-05, 1128-06, 1139-02, 1139-03, 1139-04, 1139-05, 1146-05, 1146-06, 1147-04, 1156-04, 1132-05, 1132-10, 1137-02, 1147-05, 1149-01, 1128-05, 1128-06, 1149-07, 1149-08, and 1167-02.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1368-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-23

Product code JJE

K100853Class IICobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. / cleared 2010-09-09

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)