Roche COBAS INTEGRA c111 Analyzer — Class II medical device recall Z-0387-2017
Terminated recall by Roche Diagnostics Operations, Inc., reported 2016-11-16, distributed nationwide. cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including
| Recall number | Z-0387-2017 |
|---|---|
| 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 | 2016-09-27 |
| Classified | 2016-11-09 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2017-07-21 |
| Distributed | Nationwide (US) |
| Quantity | 139 |
| Reason classes | software |
| Model numbers | 04528778001, 04777433001 |
Product
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
Reason for recall
cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.
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-0387-2017. 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.