Bracco Diagnostics Inc. recently released an update on the ongoing investigations into the safety of the CardioGen-82 generators for cardiac positron emission tomography (PET). The Food and Drug Administration (FDA) in July alerted health care professionals to stop using CardioGen-82, citing cases of increased radiation exposure due to undetected strontium breakthrough. Read the complete FDA alert
While the radiation detection investigation in not yet complete, Bracco’s letter indicates that there is no indication that the strontium breakthrough was due to product failure. The company has agreed with the FDA to engage in various follow-up activities regarding the CardioGen-82 generators to effectuate a return to the marketplace. The letter states that “the timing of the completion of these efforts is not clear, but it will unlikely be before 2012.”
The ACC is working with the American Society of Nuclear Cardiology (ASNC) to obtain the most up-to-date information about this recall, and will post additional information as it becomes available. In the meantime, ASNC has prepared a special provider Q&A that provides a summary of the actions to date and provides guidance on provider next steps.
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