Lower riskMedical device recall · FDA · Published June 7, 2024
Randox Cystatin C Reagent Recall: Missing FDA 510(k) for IVD Use
Randox recalls all CYSC Cystatin C reagents for IVD use due to missing FDA 510(k) clearance. This affects lab tests requiring the reagent. No action needed as the product is not for consumer use.
Rando: Randox Laboratories recalls all CYSC Cystatin C reagents used in lab tests because they were marketed without the required FDA 510(k) clearance. This means the reagents are not approved for in vitro diagnostic use, but they do not pose a direct risk to consumers. Read more at govinfonow.com/recall/54915-randox-cystatin-c-reagent-recall-missing-fda-510-k-for.
“Randox Cystatin C Reagent Recall: Missing FDA 510(k) for IVD Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54915-randox-cystatin-c-reagent-recall-missing-fda-510-k-for. Based on FDA recall #Z-2425-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2425-2024%22&limit=1).
The FDA announced on June 7, 2024, that Randox Laboratories Ltd. is recalling RX Series CYSC- Cystatin C Reagent kits because they are marketed without required 510(k) clearance. The agency classified the recall as Class II.
How to tell if you have it
Brand: Randox
Product: RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated
Catalogue Number: CYS4004
UPC/GTIN: 05055273208665
Quantity: 115 kits
The hazard
The RX Series CYSC- Cystatin C Reagent is being recalled because it is marketed without a 510(k). The product includes all lots of the reagent intended for in vitro diagnostic use as a Randox Cystatin C assay on automated analysers.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include the April 5, 2024, Evidence MultiSTAT Software recall for light leak risk and the March 5, 2024, Clinical Chemistry Calibration Serum recall for an inorganic phosphate bias issue. Other recent recalls of similar products include the DFI One Step K In Vitro Diagnostic Test Recall (April 2, 2026), the DFI Uric Acid Test Kits Recalled (April 2, 2026), and the QUCARE Total Cholesterol Test Recall (April 2, 2026).
How to tell if you have this one
Check for the catalogue number CYS4004 or GTIN 05055273208665 on the reagent packaging. All lots of this product are affected.
Brand
Randox
Product
RX Series CYSC- Cystatin C Reagent
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalogue number CYS4004 or GTIN 05055273208665 on the reagent packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, CA, GA, NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Georgia, New York.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2425-2024 (June 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2425-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.