Recall Z-1041-2015 ยท CGA Glucose Oxidase, Glucose
Roche Diagnostics Operations, Inc.
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
| Date | Feb 2, 2015 (initiated Dec 18, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| Action | Roche Diagnostics has confirmed an issue with the calibration and QC stability of MSS parameters for cobas b 221 <6> systems. Internal investigations identified the formation of white deposits in the fluidic system, especially in the SD cartridge tubing, as the cause for the premature failure of the MSS parameters. These white deposits can potentially affect the fluidic pathways of both the Standby solution and the calibration solutions Cal1 to Cal4 (from the S3 Fluid Pack) and may reduce the lifetime of metabolite sensor cartridges. The cause of the white deposit has been identified as a chem |
| Quantity | 103 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032311 | ROCHE DIAGNOSTICS OMNI S ANALYZER Roche Diagnostics Corp., Oct 17, 2003 |