Omni Micro-electrode/reference electrode for cobas b221 analyzer — Class III medical device recall Z-0064-2015
Terminated recall by Roche Diagnostics Operations, Inc., reported 2014-10-22, distributed nationwide. The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments.
| Recall number | Z-0064-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2014-09-12 |
| Classified | 2014-10-10 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2018-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 492 devicees |
| Model numbers | 03337103001, 03337111001, 03337111692, 03337120001, 03337138001, 03337138692, 03337146001, 03337154001, 03337154692 |
Product
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
Reason for recall
The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.
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-0064-2015. 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.