FDA Device recall Z-2597-2014
RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, sto…
- FDA Device
- Class II
- terminated
- Published 2014-09-17
On 2014-09-17 the FDA classified a Class II recall of RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, sto… by Radiometer America.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2597-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-28 |
| Published | 2014-09-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Radiometer America |
| Distribution | US |
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
Identifiers
| code_info | Verions 2.4X, 2.5X and 2.6X |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2019-02-13 · Radiometer America - ABL800 analyzer, model numbers 393-800 and 393-801
FDA Device · Class II · 2019-01-02 · Radiometer America - ABL90 FLEX analyzers with software versions 3.3MR1 or below
FDA Device · Class II · 2018-10-10 · Radiometer America - ABL800 analyzer with FLEXQ module
FDA Device · Class II · 2017-12-20 · Radiometer America
All Radiometer America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2597-2014%22
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