FDA recalls Biosite Triage Cardiac PanelPosted on May 19, 2009
Attorney Ronald E. Johnson of Schachter & Hendy concentrates on legal issues regarding defective medical devices. The company Biosite and the Federal Drug Administration (FDA) , notified health care workers professionals of a recall of the Biosite brand Triage Cardiac Panel. This is a test used by health professionals as an aid in diagnosing heart attacks.
The recall said the use of the defective devices may lead to false negative results with patients who have taken troponin 1 at very low levels, with CK-MB, and with myoglobin. This could result in missed or incorrect diagnosis. According to the recall, a false negative result could indicate that the person has not had a heart attack or heart muscle injury, when in fact they actually have.
Lot #W44467B, shipped as 25 individually pouched devices per kit box, was distributed from January 24, 2009 through February 17, 2009. On April 27, 2009, the company sent an urgent recall notice to customers who were instructed to immediately discontinue all use of, and to discard, all affected products.