The Food and Drug Administration (FDA) reports that Biosite and the FDA have notified medical professionals of a Class 1 recall of the Biosite-brand Triage Cardiac Panel. This particular panel is a test used by healthcare specialists to diagnose a heart attack (myocardial infarction). However, according to the FDA, the “use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have.”
All Biosite customers must stop using all Biosite-brand Triage Cardiac Panels immediately. Reliance upon these defective tests can lead to mistreatment of people with otherwise treatable heart conditions.
To read the entire recall, please click here.
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