In an August 20 communiqué to its customers, Bracco Diagnostics acknowledged there is a "small number" of CardioGen-82 rubidium generators available, as the company continues its phased reintroduction of the imaging agent to the market.
Bracco wrote that it is "making every effort to provide a longer and more comprehensive generator delivery schedule for those receiving generators currently, as well as a schedule for sites awaiting shipment of their first generator."
Bracco brought CardioGen-82 back on the market earlier this year after the company voluntarily recalled its generators last year in the wake of two reports that patients injected with the agent received increased radiation dose during their PET scans.
A follow-up investigation by the company and the U.S. Food and Drug Administration (FDA) found the incidents were due to user error and Bracco and its technology were not at fault.
Bracco also reinforced that the FDA requires all users to do the following:
- Complete respective training and knowledge assessments
- Have Bracco technical expertise onsite for the first two days of generator utility
- Conduct subsequent daily reporting review by the Bracco technical expert
- Complete and submit daily quality control reports
The company plans to provide additional information on the situation next month.
