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.
This recall has been terminated (originally issued July 12, 2019).
- Recall Initiated
- July 12, 2019
- Terminated
- June 17, 2020
- Recall Number
- Z-2490-2019
- Quantity
- 307 kits
- Official Source
- View on FDA website ↗
Reason for Recall
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).
Distribution
Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
Lot / Code Info
Lot Numbers: 961UE onwards GTN: 05055273200966
Root Cause
Under Investigation by firm
Action Taken
Randox Laboratories Ltd. issued Urgent Medical Device Correction letter on 7/12/19 advising users of the problem, health risk and action to take: Replace all Quality Control value sheets with the revised sheets available on www.randox.com . Discuss the contents of this notice with your Medical Director. Complete and return the response form 12187-QA to technical.services@randox.com within five working days.