Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Reported: February 11, 2015 Initiated: December 18, 2014 #Z-1041-2015
Product Description
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Reason for Recall
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 103
- Distribution
- US Nationwide distribution.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 103.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2015. Severity: Moderate. Recall number: Z-1041-2015.
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