Cobas b 221 — Class II medical device recall Z-1041-2015
Terminated recall by Roche Diagnostics Operations, Inc., reported 2015-02-11, distributed nationwide. Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to
| Recall number | Z-1041-2015 |
|---|---|
| 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 | 2014-12-18 |
| Classified | 2015-02-02 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2017-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 103 |
| Reason classes | microbial contamination, chemical contamination |
Product
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Reason for recall
Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected.
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-1041-2015. 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.