Alere Inc. has commenced a recall of certain lots of its Alere Triage meter-based cardiology products as a result of the previously disclosed concerns raised by the U.S. Food & Drug Administration, or FDA, involving the company’s quality control method for these products. The recall covers unexpired lots of Alere Triage cardiology products sold in the U.S. that do not satisfy a particular quality control method agreed upon for purposes of the recall, but allows customers who do not have an alternate testing method to continue using these lots. The FDA has agreed that the quality control method agreed upon for purposes of the recall also may be applied to the release and shipment of additional supplies of the Alere Triage meter-based cardiology products through June 30, 2012.
A total of 104 lots manufactured by Alere, constituting 803,000 individual tests, have been recalled. Tests recalled include 287,000 Alere Triage BNP tests, 46,000 Alere Triage D-dimer tests and 470,000 Alere Triage cardiology panel tests. Of the tests recalled, all of the Alere Triage BNP tests and Alere Triage D-dimer tests and 390,000 of the Alere Triage cardiology panel tests were manufactured by Alere during 2011, with the balance manufactured during the first quarter of 2012.
Alere expects to have limited inventory of its Alere Triage cardiology panels available for an unknown duration of time, but it is significantly increasing production in an effort to accommodate customer needs. Alere representatives will be working closely with customers to determine and manage product availability. As previously disclosed, Alere anticipates that its efforts to increase production will lead to increased manufacturing costs, commencing in the second quarter of 2012.
Alere and the FDA are working cooperatively to establish the quality control release method for the Alere Triage cardiology products that will apply after June 30, 2012. The FDA is considering Alere’s proposals for an interim quality control method that would remain in effect through September 30, 2012, to be followed by a final revised specification. 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.
Alere is also working with the FDA to establish the criteria against which a recall of Alere Triage TOX Drug Screen test products previously supplied will be executed, as well as an interim quality control release method and a final quality control release method for future shipments of those products. Alere expects to reach an arrangement for its Alere Triage TOX Drug Screen test products on a basis similar to what is discussed above for its Alere Triage cardiology products. However, because the quality control release methods that Alere must apply to these products in the future have not been determined, Alere is unable to determine the scope of any potential recall or the financial implications of the revised release methods.