Devices

Device Recall Cobas b 123 POC system

Model / Serial
Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including NE and AZ.
Product Description
Cobas b 123 POC system || cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of Device Recall Cobas b 123 POC system

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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