Z-2597-2014 Class II Terminated
FDA device recall Z-2597-2014 was initiated by Radiometer America Inc on July 28, 2014 and is designated Class II. The recall status is terminated (terminated October 15, 2014). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2014
- Initiation Date
- July 28, 2014
- Termination Date
- October 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
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.
Code Information
Verions 2.4X, 2.5X and 2.6X