Alere Initiates Voluntary Urgent Medical Device Correction for the Alere INRatio® PT/INR Monitor System
By: Alere Staff
Alere has initiated a Voluntary Urgent Medical Device Correction for the Alere INRatio® PT/INR Monitor System. This is important information concerning the Alere INRatio® PT/INR Monitor system (INRatio® Monitor or INRatio®2 Monitor and INRatio® Test Strips). In certain cases an INRatio® PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the certain medical conditions are present. It can also occur if the instructions in the labeling for performing the test are not followed.
For more information about the Alere INRatio® PT/INR Monitor system Voluntary Urgent Medical Device Correction, please review the customer letter dated December 5, 2014 and the press release issued on December 8, 2014.
Current patients participating in Alere Home INR Monitoring service will receive a separate letter from Alere Home Monitoring in regards to questions about how this notice relates to Home INR Monitoring service.