The FDA has announced July 11 that Alere has recalled their INRatio and INRatio2 PT/INR monitoring systems.
The devices include the INRatio or INRatio2 PT/INR Monitor and the INRatio Test Strips, the devices used to monitor blood clotting through PT/INR (prothrombin time/international normalised ratio) measures. The devices have been shown to give an incorrectly low INS result, putting the user at risk for major bleeding. The total number of recalled products include 125,5765 Test Strip kits (12 count), 24,783 Test Strip kits (48 count), 236,345 INRatio or INRatio2 Monitors.
The complete list of serial and lot numbers being recalled are as followed: 0100071, 0100139, 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7, 0100004, 0100007, 0100137, 0200431, 0200432, 0200433, 0200457, 55128A.
The distribution dates of the monitor distribution are from April 1, 2008, and the Test Strip kits from April 1, 2008, to July 8, 2016.
The Alere INRatio Recall Hotline is open to those with questions at 866-723-2535.