Biosite, FDA recall blood test kits for MI detection
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.
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.