Alere Inc. recalled INRatio® Monitors and Test Strips because they give inaccurately low results, which can cause patients to overdose on blood-thinning medications. At least 18 deaths and 1,500 injuries are linked to major bleeding.
UPDATE: Recall Issued for INRatio System
In July 2016, another Class I recall was issued for the entire INRatio System, including INRatio and INRatio2 PT/INR Monitors and Test Strips.
Overview
INRatio and INRatio2 are handheld monitors for patients on warfarin, a blood-thinning drug that prevents blood clots. They analyze a drop of blood on a test strip to help patients determine the appropriate dose of warfarin.
INRatio Helps Patients Adjust Warfarin Dosing
Patients on warfarin must routinely check their blood-clotting times and adjust the dose of warfarin depending on the results. Accuracy is extremely important. Overdosing on warfarin can cause severe bleeding — but not taking enough can result in a blood clot or stroke.
What is the problem?
The INRatio System may produce inaccurately low readings. This could result in a patient overdosing on warfarin and experiencing “major or fatal bleeding,” according to the FDA.
FDA Knew About the Problem for a Decade
Problems with false readings from the INRatio System are nothing new. The FDA issued warnings to the manufacturer in 2005 and 2006 for failing to investigate erroneous INR readings.
INRatio in Xarelto Clinical Trials
INRatio devices were used to calibrate warfarin doses in a clinical trial for Xarelto. The study concluded that Xarelto and warfarin had similar rates of bleeding, but results may have been affected by more patients on warfarin bleeding due to inaccurate INRatio readings. Janssen is now facing over 10,000 Xarelto lawsuits for failing to warn about the risk of bleeding.
INRatio Test Strips Recalled
In December 2014, a Class I recall was issued for INRatio Test Strips that produce inaccurately low readings. Alere reported 3 deaths and 18,924 complaints since 2013.
How Many People Have Been Injured?
There have been over 1,451 reports of injuries since the INRatio was approved in 2002. The FDA also received reports of 18 deaths in 2014 and 2015.
INRatio Class Action Lawsuit
In May 2016, two people who experienced “mini-strokes” after taking an inaccurate dose of blood-thinning medications filed a class action (PDF) against Alere Inc. The case is pending in the Southern District of California — In Re: Dina Andren v. Alere Inc. — Case No. 3:14-cv-01255.
List of Recalled INRatio Devices
- Alere INRatio2 PT/INR Professional Monitoring System (55128A)
- Alere INRatio2 PT/INR Home Monitoring System (0200432)
- Alere INRatio2 Replacement Monitor (Home) (0200457)
- Alere INRatio2 PT/INR Professional Testing System (0200431)
- Alere INRatio/INRatio2 PT/INR Test Strips (99007EU, 99007G1, 99007G3,99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5,99008G7)
- Alere INRatio PT/INR System Professional (0100004)
- Alere INRatio Prothrombin Time (PT) Monitoring System (0100007)
- Alere INRatio Replacement Monitor (0100137)
- Alere INRatio PT/INR Test Strips (0100071, 0100139)
Warning Signs of Internal Bleeding
Internal bleeding is the most common side effect of warfarin. Patients should be aware of the following symptoms and seek emergency medical attention if they appear:
- Severe bleeding
- Menstrual bleeding is heavier than normal
- Urine is red or brown
- Stools are black, bloody
- Severe headache
- Severe abdominal pain
- Joint pain, discomfort or swelling, especially after an injury
- Vomiting blood (may look like coffee grounds)
- Spontaneous bruising
- Dizziness or weakness
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