Alere INRatio® and INRatio® 2PT/INR Monitor Systems and INRatio Test Strips are medical devices that measure how quickly a user’s blood clots, specifically for those patients taking the medication warfarin, an anticoagulant, or blood thinner. The device and supplies are produced by Alere, Inc. The device is used at home by patients and consists of the monitor and disposable test strips. The patient places a drop of blood on the test strip, which is then inserted into the meter to analyze the blood sample. The purpose of the device is to provide an accurate reading of a user’s PT/ INR (Prothrombin time/International Normalized Ratio) levels. For those taking warfarin it is important to routinely measure INR levels because if they become unsafe (too low or too high) a person can have serious health complications that can even result in death.
Alere and the FDA have now provided recall notices regarding the Alere INRatio monitor systems and test strips as of 2014. The monitor system and test strips can malfunction, providing inaccurate INR readings that can lead to delayed treatment and thus severe or life-threatening injuries. However, even as early as 2005 Hemosense, the creator of the INRatio, which Alere purchased, was aware of the problems with the test strips. Not until April 16, 2014, did Alere recall certain test strips due to patient complaints who received an INR reading of “therapeutic” or “near therapeutic,” but who ended up having a significantly higher, and dangerous, INR level.
Then on December 5, 2014 Alere informed patients and healthcare professionals in a correction letter that incorrect results could occur. The letter discussed how patients with certain medical conditions should cease use of the device and have a lab monitor their INR levels.
On January 9, 2015 the FDA classified the recall as Class I, which is the most serious type of recall and involves situations where the INR result produced by the monitor system is significantly lower than a result obtained using a laboratory method. Inaccurate test results can cause serious health problems, or even result in death. Alere received a total of 18, 924 complaints about the INRatio Test Strips from 2013-2014.
At McDivitt Law Firm, we feel that you deserve information that may be relevant to your rights as a consumer. We want to alert you to a potential claim regarding this device that you or someone you know may have used.
We may be able to help you if:
- You or a loved one is taking the anticoagulant drug warfarin
- You or a loved one used the Alere INRatio and/or INRatio2 PT/INR Monitor System and Test Strips, and
- You have suffered injuries, especially excessive bleeding, after using Alere INRatio Monitor System and Test Strips.