RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900 — Class II medical device recall Z-0200-2024
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-0200-2024 |
|---|---|
| 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 | 35 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05055273206104 |
| Lot numbers | 7201-0348, 7201-0353, 7201-0367, 7201-0417, 7201-0423, 7201-0482, 7201-0531, 7201-0535, 7201-0562, 7201-0606, 7201-0747, 7201-0768, 7201-0776, 7201-0801, 7201-0827, 7201-0849, 7201-0901, 7201-0919, 7201-0924, 7201-0950, 7201-0970, 7201-0977, 7201-0982, 7201-1079, 7201-1080, 7201-1085, 7201-1086, 7255-0129, 7255-0171, 7255-0172, 7255-0198 |
| Model numbers | RX4900, RX4900R |
Product
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (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-0200-2024. 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.