Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
This recall is currently active, issued March 22, 2024. It was issued by Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland.
- Recall Initiated
- February 14, 2024
- Posted
- March 22, 2024
- Recall Number
- Z-1369-2024
- Quantity
- 666 units
- Official Source
- View on FDA website ↗
Reason for Recall
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Distribution
US Nationwide distribution in the states of CA, IN.
Lot / Code Info
GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
Root Cause
Under Investigation by firm
Action Taken
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 technical.services@randox.com . 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.