Sep

2014

2.5X and 2.6X Product , Cl II RADIANCE v. 2.4X

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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2.5X and 2.6X Product , Cl II RADIANCE v. 2.4X

Amy Sellers

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