S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184… — Class II medical device recall Z-2330-2015
Terminated recall by Roche Diagnostics Operations, Inc., reported 2015-08-12, distributed in CT, KY, LA, MI, ND, NJ, OH, OK…. The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 2
| Recall number | Z-2330-2015 |
|---|---|
| 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 | 2015-06-24 |
| Classified | 2015-08-05 |
| Reported by FDA | 2015-08-12 |
| Terminated | 2016-01-12 |
| Distributed | CT, KY, LA, MI, ND, NJ, OH, OK, PR, SC, TX |
| Lot numbers | 21450781, 21450887, 21451391 |
| Model numbers | 03260925184 |
| Expiration dates | 2016-08-31, 2016-09-30 |
Product
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes 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, bilirubin, 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 affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced.
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-2330-2015. 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.