Biosite brand Triage Cardiac Panel

May 28, 2009

Audience: Emergency care managers, hospital risk managers, laboratory services managers

[Posted 05/08/2009] 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. 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.

[May 08, 2009 - Recall Notice - FDA]

    

View comments

Hide
(web2)