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Recalled CardioGen-82 Linked to Radiation Overdose


CardioGen-82, which uses the radioactive drug rubidium 82 chloride injection for cardiac PET scan or cardiac PET imaging has been recalled by the manufacturer, Bracco imaging. The CardioGen-82 recall occurred after the FDA received two reports of patients who received more radiation than expected.

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CardioGen-82 Cardiac PET Scan Recall

On July 26, 2011 the FDA notified healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The CardioGen-82 was voluntarily recalled by Italian manufacturer Bracco Diagnostics.

About 10 days earlier FDA alerted the public, and in particular, the medical imaging community, about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac PET scans with rubidium (Rb)-82 chloride injection from CardioGen-82. The alert came on the heels of reports from two heart patients who set off security scanners at the U.S. border. Both patients had undergone nuclear testing at a Sarasota FL facility, and their radiation overdose was traced back to the CardioGen-82 at the facility.

About Cardiac PET Scan with CardioGen-82

CardioGen-82 consists of a generator that is used at clinical sites to produce rubidium (Rb)-82 chloride injections, a radioactive chemical tracer used to monitor blood flow through the heart. A CardioGen-82 PET scan is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate the heart. According to Heart Center, Inc., Rubidium Chloride (Rb-82), a low dose radioactive tracer as well as a chemical stress agent is injected intravenously. This test is used to assess coronary blood flow which may identify blocked coronary arteries or heart muscle damage as well as stress and rest ejection fractions (the heart's pumping capability).

FDA and CardioGen-82 Investigation

The FDA determined that the current procedures in place to manufacture CardioGen-82 were insufficient to guarantee reliable performance of the generator used to produce the rubidium 82 injection. Reliable performance is of utmost importance to ensure that patients are not subject to radiation overdose. The FDA said it is working with the Nuclear Regulatory Commission and the CardioGen-82 manufacturer to determine the root cause for the increased radiation exposure detected in the two patients. The agency is also investigating the extent to which other patients may have received inadvertent radiation exposure.

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CARDIOGEN-82 LEGAL ARTICLES AND INTERVIEWS

CardioGen-82 Reintroduced
CardioGen-82 Reintroduced Princeton, NJ A year after the CardioGen-82 recall was announced, Bracco Diagnostics announced that the CardioGen-82 received clearance to be reintroduced. When the CardioGen-82 PET recall was announced, the US Food and Drug Administration (FDA) indicated that there were some deficiencies with the generator, however more recent reports suggest the problem was with how the generator was used. Either way, it is vital that with the CardioGen-82 being reintroduced that steps are taken to ensure patients are safe [READ MORE]

Will Return of CardioGen-82 Represent a 'Glowing' Comeback?
Will Return of CardioGen-82 Represent a 'Glowing' Comeback? Washington, DC It may be funny to see poor, hapless Homer Simpson bringing the Springfield nuclear power plant to a boil and glowing green as a result, but when two CardioGen-82 heart patients set off airport security scanners after undergoing nuclear testing, the fallout is anything but humorous [READ MORE]

CardioGen-82 Study and Testing Disappears
CardioGen-82 Study and Testing Disappears Las Vegas, NV Katie had a CardioGen-82 PET Scan in March 2011 for a heart issue—results came back negative. But in July her doctor called: they wanted to talk about the PET Scan. More specifically, possible CardioGen-82 radiation exposure [READ MORE]



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