The U.S. Food & Drug Administration (FDA) has announced a Class I Recall for Alere INRatio and INRatio2 Monitoring Systems after some of the devices were found to generate incorrect low results that could cause patients to adjust the dose and suffer life-threatening bleeding events.
Update: Alere Seeks Dismissal of INRatio Class Action Lawsuit
March 21, 2017 – Alere Inc. is seeking dismissal of a class action lawsuit alleging that it misled consumers by knowingly selling inaccurate home blood coagulation tests. Plaintiffs claim that the INRatio PT/INR monitoring system often provided “significantly inaccurate results” and exposed users to risks caused by inaccurate warfarin dosing.
What is the Alere INRatio Monitor?
The International Normalization Ratio (INR) is used to monitor blood coagulation and adjust blood-thinning medications like warfarin. If a patient’s INR is too low, they may be at risk of developing blood clots or suffering a stroke. Conversely, if the INR level is too high, the patient may be at an increased risk of life-threatening bleeding events.
The Alere INRatio and INRatio2 systems and test strips are used by patients to monitor their INR levels while taking a blood thinner. Because the INR level is critical to a patient’s health, it is extremely important that the monitoring system function accurately at all times.
Which Products are Affected?
The July 12 recall affects the following products:
- 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)
2014 FDA Warning
In December 2014, FDA issued a Safety Alert stating that patients with certain medical conditions should not use its PT/INR monitoring systems. Alere reported these issues to the FDA and made software enhancements to the system.
“Although Alere is confident that the software enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, the FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market,” FDA said.
Problems with INRatio PT/INR Monitor Go Back Years
Although it may appear that inaccurate test results with the INRatio monitor have just surfaced within the last several years, the FDA actually first warned about the problem more than a decade ago. In May 2005, the agency uncovered serious problems during an investigation of San Jose, CA.-based biotechnology firm Hemosense, the company that originally developed and marketed the INRatio system before it was acquired by Inverness Medical Innovations in 2007 (Inverness changed its name to Alere in 2010). FDA determined that HemoSense had failed to report serious injuries linked to INRatio monitors and test strips.
FDA is advising patients who use an INRatio Monitoring System to consult their physician immediately about transitioning to an alternative method of PT/INR testing, such as a point-of-care (POC) monitoring system made by a different company or a plasma-based INR method. Additionally, patients should follow the precautions and recommendations found in the Dec. 2014 Medical Device Correction Notification and current product insert labeling (PDF).
BMJ Report Questions ROCKET-AF Clinical Trial Results
October 19, 2016 – A new report from The BMJ suggests that Janssen and Bayer knew about problems with INRatio monitors and test strips used during the Rocket AF clinical trial, which was used to approve the blood-thinner drug Xarelto (generic: rivaroxaban). The trial concluded that Xarelto had no significant difference in regards to the bleeding risk compared to warfarin, but did link warfarin to an increased risk for fatal bleeding in the brain (cerebral hemorrhage). However, if patients were exposed to unnecessarily higher doses of warfarin due to faulty data from an INRatio monitor, results of the study could be skewed, making Xarelto appear safer than it actually is.
Class Action Alleges INRatio Monitors, Test Strips are Defective
A class action lawsuit has been filed against Alere in California federal court on behalf of 2 people who allegedly had strokes after reducing the dosage of their blood-thinner medications based on the results of their INRatio testing kit. Plaintiffs filed the suit on behalf of themselves and a class of consumers who purchased INRatio PT/INR Monitors, INRatio TP/INR Test Strips, INRatio2 PT/INR Monitors and INRatio2 PT/INR Test Strips. The class action is: Dina Andren, et al. v. Alere Inc., et al., Case No. 16-cv-01255-GPC-NLS, in the U.S. District Court for the Southern District of California.