Alere to recall INRatio, INRatio2 PT/INR monitoring system due to potentially inaccurate results

Alere announced that it will initiate a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR monitoring system due to potentially inaccurate international normalised ratio (INR) results. The company added that it is "working with the FDA to determine the most appropriate timing for product discontinuation." 

The recall follows a voluntary correction initiated in December 2014, which informed patients with certain medical conditions that they should not be tested with the system. At that time, Alere said the system may, in certain cases, "provide an INR result that is clinically significantly lower than a result obtained using a reference INR system." Alere reported these device concerns to the FDA and initiated an investigation. 

While the company has since done research and incorporated software enhancements to "effectively address" the error, the agency said the studies "do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market."

In March, Alere defended the safety of its Alere INRatio monitor system following a report published in The New York Times, which said the FDA had received over 9000 reports of malfunctions and more than 1400 reports of injuries tied to the products since they were cleared for use in 2002. 

Commenting on the news, Abbott, which has tried to end the companies' $5.8-billion merger agreement after Alere disclosed a US investigation of its businesses practices in Africa, Asia and Latin America, said that it is disappointed by the recall, adding that it is assessing the impact on its review of Alere’s books. Abbott spokesman Scott Stoffel remarked that "Abbott is seeking to better understand this withdrawal as part of its ongoing review of financial and other information to ensure that all outstanding issues at Alere are clearly understood, including its delayed financial statements and the criminal grand jury subpoena alleging violations of the Foreign Corrupt Practices Act." 

Analysts are expecting Alere to file some financial information with the US Securities and Exchange Commission by the end of the week.  Canaccord Genuity analyst Mark Massaro noted that if Alere files a 10-K report that raises no significant new issues, the shares could return to near $56 per share, while another complication may cause the shares to fall as low as $33 a share. Alere's shares are currently trading 31 percent lower than Abbott's offer of $56 per share.