Randox RX Series Urea Enzymatic Kinetic Assay Ref — Class II medical device recall Z-2362-2023
Ongoing recall by Randox Laboratories Ltd., reported 2023-08-16, distributed nationwide. Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11
| Recall number | Z-2362-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2023-06-13 |
| Classified | 2023-08-09 |
| Reported by FDA | 2023-08-16 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05055273206906, 05055273206913, 05055273209594, 05055273209600 |
Product
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Reason for recall
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
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-2362-2023. 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.