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Recall Observatory FDA recall evidence

Device 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.

Z-2597-2014

July 28, 2014

Class II

Product summary

Firm
Radiometer America Inc
Event
Event 68982
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2597-2014

Official wording

Reason: Unavailable

Code information: Verions 2.4X, 2.5X and 2.6X

Distribution pattern: Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.