Alere INRatio Monitors and Test Strips have been recalled after being linked to at least 18 deaths and 1,500 injuries that occurred due to false readings which caused patients to overdose on blood-thinning medications.
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.
The INRatio and INRatio2 PT/INR Monitor System and INRatio Test Strips are used to measure how quickly a patient’s blood clots, and specifically measures the Prothrombin Time (PT) when taking the blood-thinning drug warfarin. The International Normalized Ratio (INR) is used to compare the results of a patient’s PT.
What’s the Problem?
It has recently been found that some INRatio and INRatio2 PT/INR Monitor System and Test Strips can provide significantly lower INR readings than those correctly analyzed through a laboratory plasma INR test, with readings from 3.1 to 12.2 units lower than clinical lab results. These false readings can result in severe medical complications because patients may be at risk for spontaneous bleeding.
- In July 2016, a Class I recall was issued for the INRatio and INRatio2 PT/INR Monitoring System, which includes the INRatio or INRatio2 PT/INR Monitor and INRatio Test Strips.
- In December 2014, Alere recalled its INRatio Test Strips after receiving at least 18,924 false reading reports since 2013. The company reported 9 adverse events, including 3 deaths.
Which Devices Have Been Recalled?
- 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)
Blood Monitor False Reading Injuries
Injuries resulting from an INRatio monitor false reading may include:
- Subdural hematoma
- Subdural hemorrhage
- Brain bleeding
- Ministroke (transient ischemic attack or “TIA”)
- Other bleeding events
Lawsuits allege that Alere knew or should have know about the problems with its INRatio monitors and test strips, yet failed to inform the U.S. government and healthcare providers. The suits also claim that Alere neglected to perform adequate testing on the devices before bringing them to market, thus resulting in needless injuries and even deaths.
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 approved 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.