Device product
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Z-2490-2019
Product summary
- Event
- Event 83373
- Status
- Terminated
- Classification
- Class III
- Quantity
- 307 kits
- Official record key
device-enforcement:Z-2490-2019
Official wording
Reason: Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Code information: Lot Numbers: 961UE onwards GTN: 05055273200966
Distribution pattern: Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
Derived failure modes
-
Unknown
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).