Device product
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
Z-1057-2019
Product summary
- Event
- Event 82195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 kit
- Official record key
device-enforcement:Z-1057-2019
Official wording
Reason: An error in the assignment of the control range pH in Blood Gas Control
Code information: Lot Code: 184BG GTIN: 05055273227116
Distribution pattern: US Distribution to state of: WV
Derived failure modes
-
Unknown
An error in the assignment of the control range pH in Blood Gas Control