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Bracco, Inc Releases CardioGen-82 Customer Update Letter
January 4, 2012
On December 29, 2011, Bracco released a customer letter to provide updated information regarding the voluntary recall of CardioGen-82 (Rubidium Rb82 Generator).
Since the voluntary recall five months ago, Bracco, has implemented several actions including:
- CardiooGen-82 Generator Voluntary Recall Process
- Clinical Assessment Program
- Rb82 Generator Quality Review Program
- Manufacturing Process Review
- Enhanced Labeling and User Training
Bracco proposed to the FDA a reintroduction plan of CardioGen-82 to user facilities, with data collection and evaluation of the actual field use of each generator Q1 2012. The FDA expressed support and the first step is to implement customer requirements in advance of commercial generator availability.
Additional information regarding the reintroduction of CardioGen-82 and generator availability will be available February 1, 2012.
To view the Bracco customer letter, please see attached.