Class II

Medical Device Recall: RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004

Randox Laboratories Ltd. · June 7, 2024

Reason for Recall

Cystatin C Reagent marketed without a 510 (k)

Distribution

US Nationwide distribution in the states of AL, CA, GA, NY.

States Affected

NATIONWIDE

Quantity Affected

115 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2425-2024

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.