Troponin and other diagnostic tests recalled

A number of cardiovascular diagnostic tests are being recalled for possible inaccuracy of their results, the FDA announced last week.

The Class I recall affects Alere Triage products, including CardioProfiler Panel PN 97100CP, Cardiac Panel PN 97000HS, Profiler SOB Panel PN 97300, BNP PN 98000XR, and D-dimer PN 98100.

According to the FDA, almost 100,000 test kits have the potential to be defective. Defective kits may have significantly lower precision than expected, which could result in increased frequency of false-positive or false-negative results. These false results are unpredictable within lots and may not be detected by quality control testing. Troponin I results of over 0.05 ng/mL for samples found to be below 0.05 ng/mL upon additional testing have been reported, as well as patients receiving inappropriate clinical management that may have been due to such erroneous results.

All of the recalled tests should be immediately discarded, although there may not currently be sufficient unaffected product to supply the product demand for all laboratories, the FDA warned.