FDA Device recall Z-2330-2015
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer
- FDA Device
- Class II
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer by Roche Diagnostics Operations, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2330-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-24 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | CT, KY, LA, MI, ND, NJ, OH, OK, PR, SC, TX |
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
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.
Identifiers
| code_info | Catalog Number: 03260925184; Lot Numbers & Exp. Dates: 1. 21450781, Exp. 08/31/2016 2. 21450887, Exp. 08/31/2016 3. 21451391, Exp. 09/30/2016 |
|---|
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-2330-2015%22
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