Update: Bracco CardioGen-82 Re-Introduction

Updated: March 26, 2012

Bracco Diagnostics Inc. has informed customers that the company's voluntary recall of CardioGen-82 is coming to an end. The recall was originally issued on July 29, 2011 in response to reports of strontium breakthrough. Bracco Diagnostics Inc. conducted a comprehensive quality assessment of all CardioGen-82 generators and found that all generators had Sr-82 and Sr-85 levels within specification limits set forth in the prescribing information. The company has also worked closely with the U.S. Food and Drug Administration to enhance the CardioGen-82 prescribing information and user training parameters. 

Bracco Diagnostics Inc. notified customers on February 14, 2012 that CardioGen-82 production has resumed and generator availability will be phased in through February and March. The company has released a CardioGen-82 Prescribing Information update in the form of training slides. This information is intended for general reference only. 

Additional Resources

Bracco Letter to Customers (PDF) 
March 26, 2012

Bracco Letter to Customers (PDF)
February 14, 2012

FDA Podcast on CardioGen-82
February 1, 2012

FDA Announces Preliminary Results of CardioGen-82 Investigation
January 12, 2012

Bracco Letter to Customers (PDF)
December 29, 2011

Updated Prescribing Information and Training Slides