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.
FDA Recall Z-2597-2014 · Posted 2014-09-06
Advertisement
Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-07-28
Date Terminated2014-10-15
Product QuantityN/A
Firm Action
Radiometer sent an Product Notification letter dated July 31, 2014 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. The letter informed customers that local RADIOMETER IT specialist will contact customers in order to schedule the upgrade to v. 2.74 or 3.5.2. All RADIANCE versions below 2.7X will be upgraded to v. 2.74 or 3.5.2.
For questions regarding this letter or the Recall, please contact Radiometer America Technical Support at 1-800-736-0600 opt.4.
Root Cause
Software design
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement