Alere Inc. is recalling 803,000 tests used to detect heart attacks and manage heart failure patients that failed to meet quality control guidelines.
The recall covers 104 lots of the Alere Triage BNP, Alere Triage D-dimer and Alere Triage cardiology panels that were produced in 2011 and the first quarter of 2012, the Waltham, Massachusetts-based company said today in a regulatory filing. The products failed to meet guidelines established by the U.S. Food and Drug Administration, the company said.
The FDA will allow new tests to be made through the end of June under a temporary quality control system while a more permanent process is discussed, Alere said. Production is being increased at an additional cost to fill the shortfall created by the recall, the company said. Alere didn’t disclose whether any patients were harmed because of the flawed tests.
“Alere is currently unable to determine the outcome of these discussion with the FDA or their impact on its future revenues, results of operations, earnings, cash flows or financial condition,” the company said in the filing. Doug Guarino, an Alere spokesman, didn’t immediately return phone calls seeking comment.
Alere fell 2.3 percent to $18.32 at the close in New York. The shares have declined 54 percent in the past 12 months.