Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RX Series CYSC- Cystatin C Reagent -Intended for in vitro Recalled by Randox Laboratories Ltd. Due to Cystatin C Reagent marketed without a 510 (k)
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories Ltd. directly.
Affected Products
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Quantity: 115 kits
Why Was This Recalled?
Cystatin C Reagent marketed without a 510 (k)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Randox Laboratories Ltd.
Randox Laboratories Ltd. has 72 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report