FDA recall Z-2425-2024

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

Reason for recall

Cystatin C Reagent marketed without a 510 (k)

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-06-07

Report date

2024-07-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2024