October 17, 2011
Dear Valued Customer,
The purpose of this letter is to provide you with the most recent information regarding the voluntary recall of CardioGen-82®
(Rubidium Rb 82 Generator).
As previously communicated, in July 2011, the U.S. Department of Homeland Security (DHS) notified the FDA about two individuals crossing U.S. borders who triggered very sensitive gamma ray emission sensors. Full body scans of those two patients at Oak Ridge National Laboratory determined the estimated amount of unexpected radiation to be minimal and similar to what other patients may receive with cumulative exposure to certain other types of cardiac imaging procedures. Our investigation regarding a third patient detected at the border remains underway.
As you know, we launched a Clinical Assessment Program which remains underway at sites having administered CardioGen-82 to patients from January 2011 through July 2011. This study is designed to capture additional information regarding incidence of unexpected exposure. Bracco Diagnostics Inc. (Bracco) has sent information regarding this clinical study to all sites and encourages all sites administering CardioGen-82 to patients within this timeframe to participate in this study.
In conjunction with the voluntary recall, customers were directed to return all recalled generators to the DOE-operated Los Alamos National Laboratory (LANL) for inventory, secure holding and investigation. Of those generators capable of being evaluated, the evaluation revealed that those generators were operating within the specifications for Sr-82 and Sr-85.
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 agency to investigate the root cause of the unexpected radiation detected in the border individuals and to address the FDAs concerns. Our investigation findings, to date, continue to support that the unexpected radiation levels may have been due to user error or strontium breakthrough higher than what is expected with normal generator use or a combination of both. Bracco and the FDA are in alignment on expeditiously returning CardioGen-82 to the market and are working closely together toward that end.
Bracco has proposed an orderly, phased reintroduction of CardioGen-82 generators to user facilities, with data collection and evaluation of the actual field use of each generator. Based on the outcome of our reintroduction discussions with the FDA, Bracco anticipates a limited and progressive reintroduction of the product to commence in the 1st or 2nd quarter of next year.
Should the FDA contact your site to request information regarding your use of CardioGen-82, your cooperation with the agencys information-gathering efforts will help support the market return of CardioGen-82. It is important for our customers and the professional societies to communicate to the FDA their experiences with CardioGen-82 and its utility in PET myocardial perfusion studies.
We know these circumstances have seriously affected our customer sites, and we appreciate the loyalty and support of our customers toward the closure of the current voluntary recall and the expeditious market return of CardioGen-82.
Kim Giordano Kim McDaniel
Vice President and General Manager Senior Director, Sales and Market Support
Nuclear Medicine Nuclear Medicine
Bracco Diagnostics Inc.
107 College Road East Princeton, New Jersey 08540 USA Telephone: (609) 514-2200 / (800) 631-5245 / Facsimile: 609-514-2424 /