Posted by: Salvatore J. Zambri, Esquire
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.
Our firm has experience pursing cases for patients that involve tragic medication errors, pharmacy mix ups and unsafe medications.
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