Bloomberg News reported, “Alere Inc. is recalling 897,000 tests used to detect heart attacks and drug use because of quality control flaws.” In detail, “The 650,000 cardiology tests are used to diagnose heart attacks and manage heart failure, while 247,000 Triage Tox tests are used by hospitals to identify 11 different substances including acetaminophen, cocaine, and marijuana.” But “the tests failed to meet interim US Food and Drug Administration quality guidelines during an inspection that is continuing.”
The Boston Herald reported that, according to the company, “A total of 650,000 individual tests — including 456,000 Alere Triage BNP tests, 2,000 Alere Triage D-dimer tests and 192,000 Alere Triage cardiology panel tests — have been recalled,” most of them made in 2011. Overall, “customers have indicated that 317,000 of such tests require no action because they were either used or will continue to be utilized due to the lack of an alternate testing method, with the balance, or 81,000 tests, either requiring refund or replacement.”
The Boston Business Journal reports, “Alere stated it does not anticipate any additional recalls associated with the inspection. The company is ramping up production of the tests, and reports it will incur increased manufacturing costs as a result.”
From the American Association for Justice news release.