CardioGen-82 Recall
On July 26, 2011, the U.S. Food and Drug Administration (FDA) alerted health care professionals to stop using CardioGen-82 for cardiac PET. CardioGen-82 consists of a generator that is used at clinical sites to produce rubidium (Rb)-82 chloride injections and the manufacturer, Bracco Diagnostics, has decided to voluntarily recall the product.
Additional Information
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Bracco Customer Letter, March 26, 2012 -
New Prescribing Information and Training PowerPoint -
Bracco Customer Letter, February 14, 2012
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Bracco Public Meeting Memo, February 1, 2012
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FDA Update on Ongoing CardioGen-82 Investigations
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Bracco Customer Letter, December 29
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Bracco Customer Letter, October 17
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Bracco Customer Letter, September 14
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Bracco Customer Letter, August 15
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Bracco Customer Letter, July 29
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FDA Alert – July 26, 2011
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Bracco Customer Letter, July 25
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FDA Alert – July 15, 2011
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Bracco Customer Letter, July 13
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FDA Drug Safety Podcast for CardioGen-82 -
SNM Letter to the FDA
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CardioGen-82 Recall FAQs
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Myocardial Perfusion Imaging Procedure Guidelines
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CardioGen.com
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Bracco.com
This page will be updated as more information becomes available.
