Recall Z-2490-2019 ยท JIX Calibrator, Multi-Analyte Mixture
Randox Laboratories Ltd.
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.
| Date | Jul 12, 2019 |
| Status | Terminated |
| 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). |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 307 kits |
| Distribution | Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053153 | RANDOX CALIBRATION SERUM Randox Laboratories, Ltd., Jan 13, 2006 |