Alere voluntarily recalled its INRatio and INRatio 2 prothrombin time/international normalized ratio (PT/INR) monitoring system, according to a July 12 announcement.
The company said that the system could provide INR results that are significantly lower than a reference INR reading conducted in a laboratory. Alere, which is based in Waltham, Massachusetts, offers meters and tests for cardiometabolic disease, infectious disease and toxicology.
In December 2014, Alere issued a warning that patients with certain medical conditions should not use its PT/INR monitoring system, which are used to monitor warfarin. The company also reported its issues with the FDA and made software enhancements to the system in the past two years.
“Although Alere is confident that the software enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, the FDA notified the company that it believes the company’s 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,” Alere said in a news release.
On February 1, Abbott agreed to acquire Alere for $5.8 billion. According to the Wall Street Journal, Abbott attempted to terminate the merger agreement after Alere was involved in foreign corruption probes. However, Alere rejected Abbott's $50 million termination offer. It is unclear how this week's recall will affect the Abbott-Alere deal.
"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," Abbott spokesman Scott Stoffel told Bloomberg.