RADIANCE v — Class II medical device recall Z-2597-2014
Terminated recall by Radiometer America Inc, reported 2014-09-17, distributed nationwide.
| Recall number | Z-2597-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2014-07-28 |
| Classified | 2014-09-05 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2014-10-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, ES, FR, GB, IN, IT, JP, NL |
Product
RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
Reason for recall
Not stated by FDA.
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-2597-2014. 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.