Recall of Biosite brand Triage Cardiac Panel
MedSun: Newsletter #37, June 2009

FDA Website

Biosite and FDA notified healthcare professionals of the Class 1 recall of the Biosite brand Triage Cardiac Panel, a test is used by health professionals as an aid in the diagnosis of a heart attack (myocardial infarction).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. 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.

Additional Information:

FDA Recall Notice. Class 1 Recall: Biosite Incorporated, Triage Cardiac Panel. April 27, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm149803.htm

Biosite brand Triage Cardiac Panel FDA MedWatch Alert. May 8, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150579.htm


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