Class II

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

Randox Laboratories Ltd. · February 14, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

666 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1369-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Randox Laboratories Ltd. Medical Device Recall: Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699 | SafeCheck