RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic — Class II medical device recall Z-2425-2024
Ongoing recall by Randox Laboratories Ltd., reported 2024-07-31, distributed nationwide. Cystatin C Reagent marketed without a 510 (k)
| Recall number | Z-2425-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2024-06-07 |
| Classified | 2024-07-24 |
| Reported by FDA | 2024-07-31 |
| Distributed | Nationwide (US) |
| Quantity | 115 kits |
| UPC / GTIN / UDI-DI | 05055273208665 |
| Model numbers | CYS4004 |
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2425-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.