Biosite Triage Cardiac Panel Test Recalled


One lot of <"">Biosite Triage Cardiac Panel tests has been recalled because of the risk they would produce a false negative test result, which could result in the test failing to diagnose a heart attack. The Biosite Triage Cardiac Panel recall is a U.S. Food and Drug Administration (FDA) Class I recall, the agency’s most serious. Class I recalls are only issued when a medical device is likely to cause serious injury or death. In this case, the tests’ poor performance likely endangered many patients and could have led to fatalities.

Biosite touts the Triage Cardiac Panel as a one-step whole blood test that aids in the diagnosis of acute myocardial infarction (heart attack). According to the company’s literature, it provides quantitative measurements of three cardiac markers—myoglobin, Creatine Kinase MB (CK-MB), and troponin I—within approximately 15 minutes.

The FDA announced that Biosite Incorporated initiated a voluntary, nationwide recall of one lot of Triage® Cardiac Panel over reports of low recovery of quality control samples containing the three markers on the affected lot; low recovery may lead to reporting of falsely low values for the markers. 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. A root cause investigation has been initiated, said the FDA.

The recall involves the Triage® Cardiac Panel, Catalog No. 97000HS, Lot #W44467B, which were shipped as 25 individually pouched devices per kit box. Biosite notified its customers via overnight mail and instructed them to discontinue use of the affected lot and discard any remaining product from that lot. This product was manufactured on January 23, 2009 and distributed to clinical labs in the U.S. between January and February 2009. Replacement product will be provided to clinical labs with remaining inventory of this affected product lot. Customers with questions may contact Biosite at 1-877-441-7440, option 2 (24 hours a day, 7 days a week).

Biosite’s Web site claims that the Triage Cardiac Panel is the only available diagnostic test that enables frequent quantitative testing of these three cardiac markers at the point of care. But if the Biosite Triage Cardiac Panel is not operating efficiently, patients can be placed in deadly danger. For instance, heart attack patients can be incorrectly diagnosed and sent home from the emergency room without receiving appropriate treatment, increasing the risk of death and disability. Unfortunately, most defective medical device injuries go unreported, which is likely the case with this defective cardiac test device, leaving patients unaware that a faulty test might be responsible for a life-threatening misdiagnosis.

As is noted in the package insert, the results of the Triage Cardiac Panel should not be used as absolute evidence of myocardial infarction and should be evaluated in the context of all the clinical and laboratory data available.

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