Home / Recalls / Medical Devices
Randox Laboratories Ltd. recalls RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated a
Recalled July 31, 2024 · FDA recall Z-2425-2024 · Randox Laboratories
Hazard
Cystatin C Reagent marketed without a 510 (k) · FDA Class II
Units
115 kits
Sold at
US Nationwide distribution in the states of AL, CA, GA, NY.
Description
Cystatin C Reagent marketed without a 510 (k)
Product
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →