Devices

Device Recall cobas b 2214Roche OMNI S4 system

Model / Serial
Catalog numbers: 3337138001 and 3337138692 UDI: 04015630018321
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
USA ( nationwide)
Product Description
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 || 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.
Manufacturer
Roche Diagnostics Corporation
1 Event
- Recall of Device Recall cobas b 2214Roche OMNI S4 system

Manufacturer

Roche Diagnostics Corporation

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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