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Recalled PET Agent Generator On Its Way Back

October 20, 2011
Written by: , Filed in: Cardiac Imaging, Diagnostic Imaging, Nuclear Medicine
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A PET heart agent generator, recalled in July after two patients set off radiation detectors at the U.S. border, may be back on the market early next year.

CardioGen-82, the generator, produces rubidium-82 chloride injections, used for PET myocardial perfusion studies. The rubidium has a half-life of 76 seconds.

But in June, two patients set off sensitive radiation detectors at U.S. borders months after undergoing PET stress tests. A third patient was found to be carrying similarly elevated levels of radiation months after the same test.

The Sarasota Herald-Tribune reported on the situation in September. (You may also have seen our Facebook post about it.) Two of the three patients had received their PET tests at the same Sarasota, Florida, cardiology center.

The incidents triggered a voluntary CardioGen-82 recall. As DOTmed News reports, the recall may have significantly reduced the number of PET scans and even affected the purchases of scanners.

On Monday, Bracco Diagnostics, the maker of CardioGen-82, sent a letter to its customers saying, “Bracco anticipates a limited and progressive reintroduction of the product to commence in the 1st or 2nd quarter of next year.” (The Society of Nuclear Medicine has an excellent Web page devoted to the CardioGen-82 issue, including links to the letter and other pertinent documents.)

Bracco said it had been “in constant communication” with the Food and Drug Administration to determine the cause of the elevated radiation in the three patients. The letter continued:

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.

“Strontium breakthrough” refers to strontium-82, used by the generator to make rubidium-82. If some of the strontium “breaks through” into the patient along with the rubidium, it can cause elevated radiation levels. Strontium has a half-life of four weeks.

Everyone, including the FDA, seems to agree that the radiation levels found in the three patients pose minimal risk, if that. And, fortunately for those who could benefit from PET stress tests, the Bracco letter says:

Bracco and the FDA are in alignment on expeditiously returning CardioGen-82 to the market and are working closely together toward that end.

Related seminar: Cardiac Imaging


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One Response to “Recalled PET Agent Generator On Its Way Back”

  1. Radiology Daily»AlertArchive » Would You Shop For X-ray Machines On eBay? on February 17th, 2012 at 10:02 am

    […] As we’ve reported, it was recalled last July after three patients were found to have elevated levels of radiation months after undergoing PET stress tests. Last fall, Bracco said its investigation traced the problems to user error, strontium breakthrough, or both. If strontium-82, used by the generator to make rubidium-82, “breaks through” into the patient, it can cause elevated radiation levels. […]