Recalls for Alere INRatio2 PT/INR Professional Test Strip

Alere Initiates Voluntary URGENT PRODUCT RECALL of Alere INRatio 2 PT/INR Professional Test Strips
05/06/2014 Food Recall

WALTHAM, Mass. – Alere Inc. (NYSE:ALR) has initiated a voluntary Class 1 recall in the U.S. of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). 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.

  • Company:
    Alere Inc.
  • Problem
    significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test.