WALTHAM, Mass., Sept. 28, 2017 /PRNewswire/ -- Alere Inc. (NYSE: ALR) (the "Company"), a global leader in rapid diagnostic tests, today announced that it has reached an agreement in principle to settle with the U.S. Department of Justice (the "DOJ") to resolve various potential civil claims, including claims under the False Claims Act, relating to Alere Triage® cardiac and Toxicology products sold between January 2006 and March 31, 2012. The settlement relates to matters arising out of the previously disclosed 2012 FDA inspection of Alere San Diego and the Office of Inspector General subpoena.
Alere issued the following statement:
We have cooperated with the DOJ investigation, and we are pleased to reach this agreement in principle that would fully resolve this matter with DOJ.
If the ongoing discussions with the DOJ are successfully concluded, we believe the total combined payment to the Department of Justice and the participating states will be within the $35 million loss contingency reserve previously taken by the Company.
Alere believes that when diagnosing and monitoring health conditions, Knowing now matters™. Alere delivers reliable and actionable information by providing rapid diagnostic tests, enhancing clinical and economic healthcare outcomes globally. Headquartered in Waltham, Mass., Alere focuses on rapid diagnostics for cardiometabolic disease, infectious disease and toxicology.
For more information on Alere, please visit www.alere.com.
Cautionary Statement Regarding Forward-Looking Statements
This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Readers can identify these statements by forward-looking words such as "may," "could," "should," "would," "intend," "will," "expect," "anticipate," "believe," "estimate," "continue" or similar words. A number of important factors could cause actual results of Alere and its subsidiaries to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, (i) the risk that the ongoing discussions with the DOJ are not successfully concluded and do not result in a settlement and (ii) the risk that any payment to settle any litigation or investigation exceeds the anticipated amounts and loss contingency reserves previously taken by the Company; and (iii) the risk factors detailed in Part I, Item 1A, "Risk Factors," of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (as filed with the Securities and Exchange Commission on June 5, 2017) and other risk factors identified herein or from time to time in our periodic filings with the SEC. Readers should carefully review these risk factors, and should not place undue reliance on our forward-looking statements. These forward-looking statements are based on information, plans and estimates at the date of this communication. We undertake no obligation to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.
SOURCE Alere Inc.