INRatio Monitors and Test Strips were recalled because they can produce inaccurately low readings. This could cause patients to overdose on blood-thinning drugs and experience severe bleeding or death.
Alere INRatio Class Action
In May 2016, a class action lawsuit (PDF) was filed by two people who say inaccurate readings on the INRatio devices caused them to take the wrong dose of blood-thinning medications. The lawsuit was filed in the U.S. District Court for the Southern District of California — In Re: Dina Andren v. Alere Inc. — Case No. 3:14-cv-01255.
What is INRatio?
INRatio® and INRatio2® are handheld devices that measure blood-clotting times, also known as Prothombin Time (PT) and International Normalized Ratio (INR). Patients on warfarin and other blood-thinning drugs must routinely check their PT/INR to adjust the dosage. Accuracy is extremely important — overdosing on blood-thinners can cause bleeding, while under-dosing can cause a stroke.
Inaccurate INRatio System Recalled
In December 2014, Alere Inc. issued a Class I recall for INRatio Test Strips and reported 18,924 complaints about low readings since 2013. However, the entire INRatio System was not recalled until July 2016. By that time, approximately 1,500 injuries were reported, including 18 deaths in 2014 and 2015.
How Low Are the Readings?
Studies show that INR readings from INRatio devices can be between 3.1 to 12.2 units lower than laboratory results, according to Alere Inc.
What is the problem?
- Severe bleeding
- Subdural hematoma
- Bleeding in the brain
- “Mini-stroke”
- Transient ischemic attack
- Stroke
- Other bleeding events
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