Devices

Device Recall S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems

Model / Serial
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
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY.
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.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of Device Recall S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems

Manufacturer

Roche Diagnostics Operations, Inc.

Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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