Company: Radiometer America Inc..
Date of Enforcement Report: 9/17/2014
Class lI:
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.
Recall Number Z-2597-2014
REASON
No reason in report.
RECALLING FIRM/MANUFACTURER
Radiometer America Inc., Westlake, OH on 7/28/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
n/a
DISTRIBUTION
Nationwide and internationally
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