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Bracco, Inc Releases CardioGen-82 Customer Update Letter
October 19, 2011
On October, 17, 2011, Bracco released a customer letter to provide updated information regarding the voluntary recall of CardioGen-82 (Rubidium Rb 82 Generator).
In support of a market return, Bracco is in the process of revalidating its manufacturing process and reviewing labeling and user training to ensure proper generator use. Bracco has been in constant communication with the FDA to investigate the root cause of the unexpected radiation detected in the border individuals and to address the angency's concerns.
Bracco and the FDA are in alignment on expeditiously returning CardioGen-82 to the market and are working closely together toward that end.
To view the Bracco customer letter, please see the attached.