Device product
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Z-1041-2015
Product summary
- Event
- Event 70023
- Status
- Terminated
- Classification
- Class II
- Quantity
- 103
- Official record key
device-enforcement:Z-1041-2015
Official wording
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.
Code information: Model/Catalog/Part #: 1. cobas b221 <6>=Roche OMNI S6 SYSTEM; and 2. 03337154692 - cobas b 221<6>=Roche OMNI S6 SYSTEM CU Potassium - CEM, Calcium - JFP, Sodium - JGS, Chloride - CGZ, Blood Gases (PCO2, PO2) and pH - CHL, Hemoglobin -GKR, Hematocrit - GKF, Oxygen saturation, Carboxyhemoglobin - GHS, Oxyhemoglobin - GGZ, Methemoglobin - KHG, Deoxyhemoglobin - GKA, Lactic Acid - KHP, Glucose- CGA, Urea Nitrogen - CDS.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Microbial contamination
bacterial contamination