Recall Z-2597-2014— Radiometer America Inc
Class II · Terminated
Class II FDA medical device recall by Radiometer America Inc, initiated 2014-07-28, terminated 2014-10-15. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Radiometer America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-28
- Terminated
- 2014-10-15
- Firm location
- Westlake, OH, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.