Cobas¿ 8000 modular analyzer series software version 03-01 — Class II medical device recall Z-1368-2013
Terminated recall by Roche Diagnostics Operations, Inc., reported 2013-05-29, distributed nationwide. When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead o
| Recall number | Z-1368-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2013-04-04 |
| Classified | 2013-05-23 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 72 units |
| Serial numbers | 1016-05, 1017-01, 1017-06, 1021-03, 1021-05, 1124-05, 1124-06, 1125-07, 1127-08, 1128-02, 1128-05, 1128-06, 1131-08, 1132-01, 1132-02, 1132-03, 1132-04, 1132-05, 1132-10, 1137-02, 1138-08, 1138-10, 1139-01, 1139-02, 1139-03 and 50 more |
| Model numbers | 05990378001 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1368-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.