Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

Randox Laboratories Ltd, UK ( manufacturer) notified the US Distributor Randox Laboratories USA . The distributor initial contact and the follow up contact via email on 2/20/24. Letter states reason for recall, health risk and action to take: We have realigned the target values in the above lot numbers to the IFCC Reference Standard. Please refer to the table below for the updated calibrator targets. You may experience a positive shift in Quality Control and patient sample recovery. If you are using CVS 2699 batch 600957 lots 1378CY-1382CY please provide proof of scrappage and a replacement calibrator lot will be provided. Please discard all copies of the calibrator Instructions For Use (IFU)s and download the updated IFUs from www.randox.com. If further information is required, please contact [email protected] . In line with the realignment to the Cystatin C Calibrator Series, we are updating the target and range for the Cystatin C controls, CYS5019 and CYS5020. The updated target and range can be found in the table below. Please discard any copies of the IFU and download the updated version from www.randox.com.