Faulty Biosite Triage Cardiac Panels Recalled

May 2009

Biosite Incorporated has announced a nationwide recall of one lot of its Triage Cardiac Panel. The test is used by healthcare professionals to aid in the diagnosis of myocardial infarction, or heart attack, and the affected lot may not work properly.

Biosite received reports of low recovery of quality control samples containing Creatine Kinase MB (CK-MB), troponin I, and myoglobin on the recalled lot. Low recovery may lead to the inaccurate reporting of low values for CK-MB, troponin I, and myoglobin, which could interfere with the diagnosis of a heart attack. Biosite has initiated an investigation into the cause of the malfunction.

The recall involves the Triage Cardiac Panel, catalog number 97000HS, lot number W44467B. Biosite has notified its customers and has instructed them to discontinue use of the affected lot. The product was distributed to clinical labs in the United States between January and February 2009, and replacement products will be provided.