Alere INRatio medical devices have been recalled and lawsuits may be brought against the manufacturer, alleging the device is defective. You could be entitled to receive compensation for your medical bills, lost income and pain and suffering, among other losses. We are working with experienced Alere lawyers, who charge no fee unless you receive an award or settlement. Contact us 24/7 toll-free or online for a free (no obligation) case evaluation.
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What Is Alere INRatio Used For?
The Alere INRatio system is a device that monitors how well blood is clotting in patients taking warfarin. Similar to a diabetic blood glucose monitor, the device tests a small amount of blood to determine the correct dosage of warfarin. The device is made by Alere, a Massachusetts based company.
Why Are Alere INRatio Claims Being Brought?
Alere has issued recalls for some of its products – the Alere INRatio 2 Professional Test Strips, the Alere INRatio Monitor and the Alere INRatio 2 PT/INR Monitor. The device has been linked to at least nine reported serious adverse events, as well as at least three deaths. It was recalled because the device sometimes reports normal INR results even though the patients’ INR is very high or very low. The bad readings may have led to patient deaths.
Claims, which may lead to lawsuits, allege that Alere knew its products were defective, but marketed them as safe anyways and waited too long to recall them. As early as 2005 Alere, known then as HemoSense, warned investors that the device could produce inaccurate results, and that doctors did not always know how to use the product.
Why Has the FDA Recalled the Device?
In April of 2014, the FDA issued a Class I recall (the most serious kind of recall) for the Alere INRatio 2 Test Strips. The FDA learned that at least three people had died from receiving inaccurate results from the product and at least six others were seriously injured because of it. This recall was for strips that were used by medical professionals in doctors’ offices, but not the ones that patients could use in their own home.
Then, in December of 2014, the FDA issued another Class I recall for the Alere INRatio products that are used at home. This recall noted that there had been almost 19,000 complaints about the INRatio Test Strips. The recall was issued for not just the INRatio Strips, but also the Monitors. The recall noted that conditions such as anemia, inflammation, or infection could dramatically affect the results of the INRatio test.
What Is Warfarin?
Warfarin is a drug that has been used as a blood thinner since 1954. It is used to treat people that have suffered heart attacks, or that have artificial heart valves, deep venous thrombosis, or pulmonary embolisms. It works by making it difficult for the blood to coagulate and form clots, which allows blood to flow easier in the body. However, this means that people taking warfarin are vulnerable when they start to bleed, so they need to carefully monitor their blood.
Why Hire Us?
If you or a loved one suffered an injury while using the Alere INRatio device, you could be entitled to compensation for medical bills, lost income and pain and suffering, among other losses. We are working with some of the more experienced Alere INRatio lawyers in the country, who charge no legal fee unless you get an award or settlement. Contact us 24/7 toll-free or online for a free (no obligation) case evaluation.