Alere, a medical device manufacturer headquartered in Massachusetts, voluntarily recalled their Alere INRatio and INRatio 2 PT/INR Monitor Systems and INRatio Test Strips in December 2014 because they can give false readings. In just 1 year (2013-2014), the FDA received almost 19,000 complaints about the devices, although some of the complaints were not related to the recall. Additionally, Alere itself has received at least 9 serious adverse event reports, 3 of which were linked to patient deaths.
The FDA has stated that the reason for the recall is that the Alere INRatio systems and INRatio Test Strips may provide an International Normalized Ratio (INR) result that is lower than expected when compared to an INR result performed by a laboratory. An INR test is a test designed to check how well your blood clots, and it does so by measuring the time required for the blood to clot.
The FDA has also stated that patients with certain medical conditions can get a false reading from Alere INRatio systems and INRatio Testing Strips. The medical conditions which could lead to a false test result include anemia, elevated fibrinogen levels, or unusual bruising or bleeding. Not performing tests properly can also be a causal factor in a false reading, says the FDA.
The purpose of the Alere INRatio systems and INRatio Test Strips is to provide convenient, at-home testing for people who are taking a blood thinner like Warfarin and need to constantly monitor their blood clotting. Because of the false readings that the Alere INRatio systems and INRatio Test Strips can give, doctors may not know whether or not to make adjustments in their patient’s Warfarin dosage, which could lead to serious injuries or even death.
If you or a loved one have been injured from using an Alere INRatio system or INRatio Testing Strips, call the Merman Law Firm today for immediate assistance.