Z-2330-2015 Class II Terminated
FDA device recall Z-2330-2015 was initiated by Roche Diagnostics Operations, Inc. on Jun 24, 2015 and is designated Class II. 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… The recall status is terminated (terminated Jan 12, 2016). Affected quantity: 19 affected devices of lot 21450781 were distributed in the US.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 12, 2015
- Initiation Date
- Jun 24, 2015
- Termination Date
- Jan 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 affected devices of lot 21450781 were distributed in the US.
Product Description
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.
Distribution Pattern
US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2330-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026