The COBAS INTEGRA 400/400 plus system — Class II medical device recall Z-0490-2013
Terminated recall by Roche Molecular Systems, Inc., reported 2012-12-19, distributed nationwide. Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
| Recall number | Z-0490-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2012-07-16 |
| Classified | 2012-12-07 |
| Reported by FDA | 2012-12-19 |
| Terminated | 2015-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 855 units |
| Reason classes | software |
Product
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Reason for recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
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-0490-2013. 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.