Roche Diagnostics Operations, Inc. recalls Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
- Recall date
- December 18, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1041-2015
- FDA classification
- Class II
- Brand / firm
- Roche Diagnostics Operations, Inc.
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
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