Recall Z-1041-2015— Roche Diagnostics Operations, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2014-12-18, terminated 2017-02-06. It names one FDA 510(k) clearance: K032311. Product: Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer. Reason: 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..
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-18
- Terminated
- 2017-02-06
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.