Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated ana

FDA device recall Z-1369-2024 · posted 2024-03-22 · Open, Classified

Recall details

Recalling firm

Randox Laboratories Ltd.

Reason for recall

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

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NDY

Quantity affected

666 units

Distribution

US Nationwide distribution in the states of CA, IN.

Date initiated

2024-02-14

Date posted

2024-03-22

Location

Crumlin, North, Ireland