Alere INRatio Monitors and Test Strips have been recalled because they may produce false readings. At least 18 deaths and 1,500 injuries from major bleeding have occurred when patients overdosed on blood-thinning medications.
UPDATE: Alere Recalls INRatio System
In July 2016, Aere Inc. issued a Class I recall for the INRatio® and INRatio®2 PT/INR Monitoring System, which includes the INRatio® or INRatio2® PT/INR Monitor and the INRatio® Test Strips.
Overview
The INRatio Monitor is a handheld device that measures blood-clotting times by reading test strips. It is used by patients on the blood-thinning drug warfarin to determine the appropriate dose of their medication.
What is the problem?
The monitor may produce inaccurately low readings. This could result in a patient taking an overdose of warfarin, substantially increasing their risk of “major or fatal bleeding,” according to the FDA.
Risk Factors for Major Bleeding
The risk of bleeding increases for patients with certain medical conditions. In December 2014, the FDA warned against using the INRatio System in patients with anemia, bleeding or unusual bruising, or any condition associated with elevated fibrinogen levels.
How Many People Have Been Injured?
INRatio was associated with 1,451 injury reports to the FDA, according to the New York Times. At least 18 deaths in 2014 and 2015 were also linked to inaccurate readings on the INRatio System, according to MassDevice.
How Long Has the FDA Known About the Problem?
In 2005 and 2006, the FDA issued warning letters to HemoSense — the device’s manufacturer at the time — for failing to act on complaints that INRatio Monitors were giving erroneous results.
INRatio in Xarelto Clinical Trials
Xarelto is a blood-thinning drug that was approved based on a clinical trial known as ROCKET-AF, which concluded that Xarelto and warfarin had similar rates of bleeding. However, patients on warfarin used defective INRatio devices to calibrate their dose, which may have caused extra bleeding and skewed results of the study. Janssen is facing over 10,000 lawsuits for downplaying Xarelto’s bleeding risk.
INRatio Test Strip Recall
In December 2014, Alere Inc. issued a Class I recall for INRatio Test Strips after receiving a total of 18,924 complaints since 2013. The company reported nine adverse events, including three deaths.
Full List of Recalled 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)
Symptoms of Internal Bleeding
Because bleeding can occur in many parts of the body, patients should seek emergency medical attention for symptoms such as:
- Severe bleeding, including heavier than normal menstrual bleeding
- Red or brown urine
- Black or bloody stool
- Severe headache or stomach pain
- Joint pain, discomfort or swelling, especially after an injury
- Vomiting of blood or material that looks like coffee grounds
- Bruising that develops without an injury you remember
- Dizziness or weakness
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