Alere Inc. is recalling 897,000 tests used to detect heart attacks and drug use because of quality control flaws, doubling the number of products the company said should be withdrawn from the market. 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. Most of the products were manufactured last year, the company said in a regulatory filing Tuesday.
The tests failed to meet interim US Food and Drug Administration quality guidelines during an inspection that is continuing, the Waltham-based company said. Alere is in talks with the agency to determine the final requirements for the release of new products after September.
Doug Guarino, a spokesman for Alere, declined to comment further about the recalls.
Alere has heard from customers buying about half the 803,000 tests that were recalled last month. Most were already used or will be used by the hospitals because they have no other testing options, the company said. Customers will receive a refund or replacement tests for 81,000 remaining products. There will be a limited number of cardiology tests available until Alere is able to increase its production, the company said.
Alere fell 0.4 percent to $18.88 at 10:52 a.m. New York time. The shares had declined 49 percent in the past 12 months through Monday.