FDA-Device2015-02-11Class II
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Roche Diagnostics Operations, Inc.
Hazard
Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected.
Sold states
US Nationwide distribution.
Affected count
103
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2015Don't want to check this manually?
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