Certain lots of Alere Triage cardiac diagnostic tests have been recalled because their use could result in an increase in false-positive or false-negative results, the Food and Drug Administration announced on July 11.
The recall may affect laboratory supplies: The statement says that there may not be enough of these products unaffected by the recall to meet the demand in all laboratories.
The recalled products – used to aid in the diagnosis of heart failure, myocardial infarction, and other conditions – are the Triage CardioProfiler Panel PN 97100CP, Triage Cardiac Panel PN 97000HS, Triage Profiler SOB Panel PN 97300, Triage BNP PN 98000XR, and Triage D-dimer PN 98100, according to a letter issued by the manufacturer, Alere San Diego.
As many as 98,100 test kits may be defective, the FDA statement said.
"There have been reports of patients receiving inappropriate clinical management which may have been due to such erroneous results," and the product "may cause serious adverse health consequences, including death," according to the FDA statement. Quality control tests may not detect false-positive and false-negative results within lots, which are unpredictable, the statement said. For example, some lots affected by the recall provide a troponin I result that is greater than 0.05 ng/mL, which additional testing determines is lower than 0.05 ng/mL.
The manufacturer is advising that the affected product be discarded, and that unaffected lots or other methods of performing these analyses be used instead.
The lot numbers of the recalled products are available at www.alere.com/assets/articles/TriageProductRecallLotsMay22.pdf.
The recall was initiated in May.
The recall notice is available at www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm311405.htm. The manufacturer can be contacted at 877-308-8287. Adverse events associated with any of these products should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.