Roche Heart Attack Test Kit Recall Issued Over False Results
Roche is recalling test kits used to determine heart damage following a heart attack, after reports suggest that the kits may give false low results to doctors.
The Elecsys Troponin Immunoassay recall was announced by the FDA on April 24, after the agency determined that the problem with the test kits constituted a Class I medical device recall.
A Class I designation is the most serious category of medical device recall, suggesting that the FDA believes there is a reasonable possibility that the use of the kits may lead to serious injury or death.
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Elecsys Troponin Immunoassays are test kits used by doctors to determine how much damage has been done to the heart when diagnosing a heart attack.
According to the FDA, certain plasma samples analyzed by the kits could tell doctors there is as much as 50% less Troponin I in a test result than there actually is in the sample. This can lead to an underdiagnosis of heart damage and could cause severe injury or death of a patient if the doctor acts based on the falsely low readings.
The recall affects the Elecsys Troponin I and Elecysis Troponin I STAT Immunoassays with lot numbers 163176 and 163177. The kits were distributed by Roche Diagnostics Operations from June 29, 2011 through January 13, 2012.
Customers have been instructed to immediately discontinue use of the affected products, discard the kits form their inventories and contact anyone else they may have redistributed the kits to and warn them of the problem. Consumers with questions can call Roche Diagnostics Technical Support at (800) 428-2336.
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