RX Daytona Plus — Class II medical device recall Z-0199-2024
Ongoing recall by Randox Laboratories Ltd., reported 2023-11-08, distributed nationwide. RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample r
| Recall number | Z-0199-2024 |
|---|---|
| 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 | 2023-09-06 |
| Classified | 2023-10-31 |
| Reported by FDA | 2023-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05055273207781 |
| Lot numbers | 7241-0149RX, 7241-0384, 7241-0425, 7241-0441, 7241-0582, 7241-0616, RX4041R |
Product
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Reason for recall
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
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-0199-2024. 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.