Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
Products Sold
GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C as due to Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026