A Medical Device Daily
Biosite (San Diego) has initiated a voluntary, nationwide recall of one lot of Triage Cardiac Panel. The test is used by healthcare professionals as an aid in the diagnosis of myocardial infarction. 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. A root cause investigation has been initiated.
The recall is limited to the Triage Cardiac Panel, Catalog No. 97000HS, Lot #W44467B. Biosite has notified its customers 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 clinical labs in the U.S. between January and February. Replacement product will be provided to clinical labs with remaining inventory of this affected product lot.