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

Recalled April 3, 2024 · FDA recall Z-1369-2024 · Randox Laboratories

Hazard

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

Units

666 units

Sold at

US Nationwide distribution in the states of CA, IN.

Description

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

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

Manufacturer(s)

Randox Laboratories Ltd.

Made in

Ireland

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →