Alere Voluntary Urgent Product Recalls of INRatio®2 PT/INR Test Strips-Test Results May Not Be Accurate
Posted May 07 2014 4:46pm
This is kind of urgent as nine adverse events have been reported with three patients experiencing bleeding associated with deaths. The results are showing lower than a lab test which means you can’t count on what’s being shown. All are urged to immediately stop use of the product and use an alternative method to perform testing. The company has an alternative Alere product that can be used.
The company has requested that all products be returned. BD
WALTHAM, Mass., May 6, 2014 /PRNewswire/ -- 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.
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 Alere INRatio2 PT/INR Professional Test Strip results were between 3.1 -- 12.2 INR units lower than the laboratory result.
Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.