Randox Laboratories Ltd. recalls RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated…
- Recall date
- June 7, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2425-2024
- FDA classification
- Class II
- Brand / firm
- Randox Laboratories Ltd.
- Sold / distributed
- US Nationwide distribution in the states of AL, CA, GA, NY.
Why it was recalled
Cystatin C Reagent marketed without a 510 (k)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
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