FDA Device recall Z-0064-2015
Omni Micro-electrode/reference electrode for cobas b221 analyzer
- FDA Device
- Class III
- terminated
- Published 2014-10-22
On 2014-10-22 the FDA classified a Class III recall of Omni Micro-electrode/reference electrode for cobas b221 analyzer by Roche Diagnostics Operations, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0064-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-09-12 |
| Published | 2014-10-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
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
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.
Identifiers
| code_info | Model/Catalog/Part Number: 1. 03337103001 2. 03337111001 3. 03337154001 4. 03337138001 5. 03337120001 6. 03337146…Model/Catalog/Part Number: 1. 03337103001 2. 03337111001 3. 03337154001 4. 03337138001 5. 03337120001 6. 03337146001 7. 03337111692 8. 03337138692 9. 03337154692 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0064-2015%22
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