Biosite and FDA notified healthcare facilities and clinicians of the recall of Biosite® brand Triage Cardiac Panel
Biosite and the Food and Drug Administration have recently notified emergency room and hospital laboratory personnel of a Class 1 recall of the Biosite brand Triage Cardiac Panel. FDA defines a Class 1 recall as “the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death. “
The Biosite ®Triage Cardiac Panel is a test used by hospitals and clinics to assist medical professionals in making the diagnosis of a heart attack. On April 27, 2009, the company sent an urgent recall notice to hospitals and clinics. Facilities were instructed to immediately stop using the tests, and to throw away all packages showing the recalled lot number. Using test kits from the defective lot may lead to false negative results in blood samples containing very low levels of the blood markers used to determine heart damage.
These inaccurate test results can possibly mean that heart attacks, especially in the early stages, were incorrectly diagnosed or missed completely as clinicians relied on incorrect test results as a part of making a correct diagnosis. The defective test kits might not have been sensitive enough to detect low levels of the blood markers to indicate that a person had a heart attack or other damage to the heart muscle.
Testing packets with the recalled lot number were sold to hospitals and clinics from January 24, 2009 through February 17, 2009. If you or a loved one has recently been treated for heart related chest pain or other heart related symptoms, and early signs of a heart attack were missed or incorrectly diagnosed, you may be entitled to compensation.
If you would like to view the complete recall notice, you may do so at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Panel

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