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.
This recall has been terminated (originally issued September 6, 2014).
- Company
- Radiometer America Inc
- Recall Initiated
- July 28, 2014
- Posted
- September 6, 2014
- Terminated
- October 15, 2014
- Recall Number
- Z-2597-2014
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Distribution
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.
Lot / Code Info
Verions 2.4X, 2.5X and 2.6X
Root Cause
Software design
Action Taken
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.