Biosite and the FDA have notified healthcare professionals of the Class 1 recall of the Biosite brand Triage Cardiac Panel, a test used by health professionals as an aid in the diagnosis of a heart attack.
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 diagnoses. 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.
The recalled Lot #W44467B, shipped as 25 individually pouched devices per kit box, was distributed from Jan. 24 through Feb. 17. On April 27, the San Diego-based company sent an urgent recall notice to customers who were instructed to immediately discontinue all use of, and to discard, all affected products.