Biosite has initiated a voluntary, nationwide recall of one lot of Triage Cardiac Panel, a test used as an aid in the diagnosis of MI.
The San Diego-based company said 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.
Biosite said it has initiated an investigation into the cause.
The recall is limited to the Triage Cardiac Panel, Catalog No. 97000HS, Lot #W44467B, according to the company. Biosite has notified its customers via overnight mail and has instructed them to discontinue use of the affected lot and discard any remaining product from the lot that is on hand. The identified lot was distributed to U.S. clinical labs between January and February. Biosite said that replacement products will be provided to clinical labs with remaining inventory of this affected product lot.
Biosite has reported the action to the FDA.