There has been a Class I recall of Alere INRatio and INRatio2 PT/INR monitoring devices manufactured by Alere Inc. These devices are used to monitor blood clotting time as measured by PT/INR values in people taking blood thinning medication, including warfarin (also known as Coumadin). A Class I recall, the most serious type of recall, is issued when the continued use of the recalled devices may cause serious injuries or death.

Essentially, the monitoring devices have been found to generate incorrect readings in certain circumstances. Such incorrect readings can result in improper anticoagulation dosing, which can lead to the risk of major or fatal bleeding.

Alere has been unable to develop an adequate modification to ensure the safety and effectiveness of their PT/INR monitoring devices, and the following Alere INRatio devices are subject to the recall:

• INRatio2 PT/INR Professional Monitoring System (55128A)

• INRatio2 PT/INR Home Monitoring System (0200432)

• INRatio2 Replacement Monitor (Home) (0200457)

• INRatio2 PT/INR Professional Testing System (0200431)

• INRatio/INRatio2 PT/INR Test Strips (99007EU, 99007G1, 99007G3,99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5,99008G7)

• INRatio PT/INR System Professional (0100004)

• INRatio Prothrombin Time (PT) Monitoring System (0100007)

• INRatio Replacement Monitor (0100137)

• INRatio PT/INR Test Strips (0100071, 0100139)

(The recalled devices and test strips were distributed from April 1, 2008 to the middle of this year.)