FDA Classifies Alere INRatio, INRatio 2PT/INR System and INRatio Test Strip Recall as Class 1 Recall

On December 5th, 2014, medical device manufacturer Alere issued a voluntary recall of their Alere INRatio, INRatio 2PT/INR System and INRatio Test Strips because they can give a false (low) reading. INRatio products are used by people on blood thinners, who must constantly monitor their anti-coagulation levels. If a person who is on blood thinners receives an incorrect reading, they can suffer a serious bleed or even death.

Alere’s INRatio Systems and Test Strips are designed to monitor a person’s anti-coagulation when they are on blood thinners such as Warfarin. INRatio Systems and Test Strips do this by calculating the INR (International Normalized Ratio), a result of the Prothrombin Time (PT) test, which measures how long it takes a person’s blood to clot. Unfortunately, Alere’s INRatio Monitors and Testing Strips can give much lower INR readings than laboratory INR testing, making the product too inaccurate (and dangerous) to rely on for many patients.

After Alere issued their voluntary recall, the FDA classified the recall as a “Class 1” recall, the most serious type of recall. The FDA defines a Class 1 recall as “a situation in which there is a reasonable probability that the use or exposure to violative product will cause serious adverse health consequences or death.”

It is clear why the FDA classified it as such, because in just one year (2013-2014), there were almost 19,000 adverse event reports received by the FDA arising out of the use of Alere INRatio products (some unrelated to the recall). Additionally, Alere itself had received at least 9 adverse reports (3 of which linked to patient deaths).

The Alere INRatio recall affects INRatio and INRatio 2 Monitors as well as INRatio Test Strips manufactured from April 1, 2008 through December 4, 2014. The FDA and Alere are recommending that patients who suffer from anemia, conditions with elevated fibrinogen levels or unusual bleeding or bruising cease using INRatio products until they discuss the risks with their doctors. Additionally, all patients using Alere INRatio products have been advised to get periodic laboratory INR testing to verify the accuracy of their INR tests.

Alere is currently working on making some improvements to their INRatio Monitors and Testing Strips, in the hopes that the new products will allow more accurate results.