Randox RX Imola Analyser with ISE — Class II medical device recall Z-2013-2021
Terminated recall by Randox Laboratories Ltd., reported 2021-07-14, distributed nationwide. An issue was identified where the software froze during processing of commands, which resulted in no results d
| Recall number | Z-2013-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2021-04-28 |
| Classified | 2021-07-06 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2021-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 50 kits |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05055273206104 |
| Serial numbers | 7201-0112, 7201-0231, 7201-0275, 7201-0299, 7201-0319, 7201-0343, 7201-0348, 7201-0353, 7201-0367, 7201-0381, 7201-0391, 7201-0417, 7201-0423, 7201-0434, 7201-0482, 7201-0513, 7201-0514, 7201-0515, 7201-0531, 7201-0533, 7201-0535, 7201-0540, 7201-0562, 7201-0605, 7201-0606 and 24 more |
| Model numbers | RX4900, RX4900R |
Product
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Reason for recall
An issue was identified where the software froze during processing of commands, which resulted in no results displayed.
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-2013-2021. 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.