aleres inratio system recalled for putting warfarin patients at risk for life threatening blood Injuries
In July 2016, Alere began its voluntary recall of INRatio® and INRatio®2 Monitoring Systems from the market because of incorrect low INR/anti-coagulation readings, which has resulted in patients being at risk of having major or fatal bleeding issues.
Included in the recall are INRatio®, INRatio2® PT/INR Monitor the INRatio Test Strips. These handheld devices are designed for medical professional and home use and monitor blood clotting time measured by PT/INR in those who take warfarin, often known by its brand name, Coumadin®.
Problems with INRatio began several years ago with Alere at one point reporting close to 19,000 complaints to the Food and Drug Administration. Previously, a Class I recall was issued for all Alere INRatio Monitor system and test strips manufactured between April 2008 and December 2014. It has been reported that at least three deaths and numerous injuries were caused by faulty INRatio test results.
More than two-million Americans begin taking warfarin each year. These patients may include mechanical heart valve recipients, those diagnosed with atrial fibrillation/irregular heart arrhythmias or even patients recovering from hip or knee surgery. warfarin is an anticoagulant, which helps mitigate the patient’s risk for developing harmful, sometimes deadly, blood clots, which can lead to stroke.
An important aspect of anticoagulation therapy is monitoring blood clotting time so patients and medical professionals can correctly determine the amount of the medication that is needed. Much like a diabetic patient tests their blood sugar, a patient taking warfarin tests their blood’s ability to clot.
When Alere patients read the incorrectly low results of their PT/INR tests on the INRatio System, they had now idea that by adjusting their warfarin dose they were putting themselves at risk for a major, life-threatening medical issue.
If you or a family member have been injured or died due to a serious bleeding issue while using an Alere INRatio PT/INR Monitor System, then you may have a claim against Alere and Meyers & Flowers can help.
We are dedicated to taking on pharmaceutical companies, such as Alere, and holding them accountable for injuries, errors and, in some cases the deaths, of our clients. Contact us at email@example.com, (630) 232-6333 or find out how we can help here.