A recall has been issued for the VITROS Immunodiagnostic Products Troponin I Reagent Pack, a medical test used to diagnose heart attack or injury to the heart muscle. The recall refers specifically to lot numbers 3151 and 3170.
The defect in the VITROS Immunodiagnostic Products Troponin I Reagent Pack could cause false-negative results. This would lead to patients who have suffered heart attack or heart injury to be misdiagnosed. In such cases, these patients would be cleared as healthy when in fact they could be subject to serious risks from deteriorating cardiac condition.
This is not the first major recall of the VITROS Immunodiagnostic Products Troponin I Reagent Pack. In 2004, four different lot numbers were shelved due to reports of random false-positive tests. This meant that patients who did not experience heart attack or injury were put through unnecessary medical procedures and subject to harm.