FDAFDA · Food and drugs·Recall number Z-2597-2014
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.
Published September 17, 2014 · Recall initiated: July 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Radiometer America Inc
- Distributor
- 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
- Verions 2.4X, 2.5X and 2.6X
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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