RX Imola — Class II medical device recall Z-2059-2018
Terminated recall by Randox Laboratories, reported 2018-06-13, distributed in PR, WV. Abnormal premature termination of the software could affect the use of the analyser when running patient sampl
| Recall number | Z-2059-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Kearneysville, WV, United States |
| Recall initiated | 2018-05-04 |
| Classified | 2018-06-04 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-06-16 |
| Distributed | PR, WV |
| Quantity | 41 analyzers |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05055273206104 |
Product
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Reason for recall
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting 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-2059-2018. 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.