Alere initiates voluntary recall of the of the Alere INRatio2 PT/INR Strips Alere has initiated a voluntary Class 1 recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips. This action is a result of complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. Alere has received nine serious adverse event reports, three of which described bleeding associated with patient deaths. The reason for the adverse event reports was significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test. The root cause for this issue has not yet been determined; therefore Alere cannot determine the patient conditions or circumstances that may contribute to the discrepancy.
Zwanziger says Alere will not provide due diliegence Ron Zwanziger disclosed that he sent an email to Gregg Powers, Alere's Chairman of the Board, seeking a meeting to discuss the proposed due diligence period. Zwanziger also noted that representatives from a private equity firm and an investment bank would accompany him to the meeting to discuss equity and debt financing related to the proposed transaction and to assure Mr. Powers that the proposal is and will be bona fide. Zwanziger said Powers responded by letter, declining the proposed meeting. He also indicated that Alere would not be providing any due diligence opportunity to the former officers. Powers also stated in the Alere Letter that the board would appropriately consider any proposal it believes to be bona fide and would maximize shareholder value.