Biosite Incorporated, in cooperation with the U.S. Food and Drug Administration (FDA) has issued a nationwide recall of certain Triage Cardiac Panels. Health professionals use the test as an aid in the diagnosis of heart attack patients.
The product has been recalled due to reports of low recovery of quality control samples containing Creatine Kinase MB (CK-MB), troponin I and myoglobin on the affected lot. Although there have been no reported issues of patient misdiagnosis associated with this lot to date, low recovery may lead to reporting of falsely low values for CK-MB, troponin I and myoglobin.
The recall is limited to Triage® Cardiac Panel, Catalog No. 97000HS, Lot #W44467B.
Biosite has sent overnight letters to patients to warn them to discard any of the affected product.
Consumer Information: Contact the company for more information at 1-877-441-7440, option 2 (24 hours a day, 7 days a week)