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WASHINGTON -- The FDA has issued a Class I recall on several lots of cardiovascular diagnostic tests because of a potentially fatal sensitivity error that increases the rate of false positive and false negative results.
The affected Triage CardioProfiler Panel, Cardiac Panel, Profiler SOB Panel, BNP, and D-dimer tests do not provide the precision described in the package insert, the agency wrote in a statement.
The false results are unpredictable within lots and cannot be distinguished through quality control sampling, the agency noted.
The recall affects 49 lots of products, which were manufactured from June 12, 2011 to April 8, 2012 and distributed from Sept. 8, 2011 to June 5, 2012. An estimated 98,100 units are affected by the recall.
The devices are indicated as a rapid diagnostic test system for conditions including heart failure and MI and are used to aid in assessing pulmonary embolism.
Manufacturer Alere issued an urgent recall notice on May 22, 2012, following reports of inappropriate clinical management because of the erroneous results.
A follow-up notice issued June 11, 2012 added additional product lots to the recall, and a third letter, issued one day later, added three more lots. The third notice also notified customers of increased frequency of false positive troponin I results in the newly-listed units.
Class I recalls affect products with a reasonable risk of serious adverse events or death with use.