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Roche Diagnostics Operations, Inc. recalls Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Recalled February 11, 2015 · FDA recall Z-1041-2015 · Roche Diagnostics Operations
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. · FDA Class II
Units
103
Sold at
US Nationwide distribution.
Description
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.
Product
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →