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.
Alere upgraded to Buy from Neutral at Goldman Goldman upgraded Alere to Buy and increased its price target to $60 from $50. The firm believes management's focus on improving the cost structure and potential for improved execution is underappreciated. Goldman sees margin leverage driven by new product launches, manufacturing and sourcing initiatives, and slowing regulatory headwinds. Further, potential divestitures of non-core assets will continue to de-leverage the balance sheet.