Recall Z-1369-2024 ยท NDY Test, Cystatin C
Randox Laboratories Ltd.
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
| Date | Mar 22, 2024 (initiated Feb 14, 2024) |
| Status | Open, Classified |
| Reason | Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods |
| Root cause | Under Investigation by firm |
| Action | 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 ca |
| Quantity | 666 units |
| Distribution | US Nationwide distribution in the states of CA, IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.