Alere Inc. has initiated a recall of the company’s Alere INRatio and INRatio2 prothrombin time/international normalized ratio (PT/INR) monitoring system. The Alere recall was issued on July 12, 2016. This recall comes after a number of patients have filed Alere INRatio lawsuits alleging these false results were causing serious injuries.
Alere indicated on its website that the Alere INRatio and INRatio2 could provide INR results that are significantly lower than reference INR results from a laboratory. Alere said in a statement that it developed and submitted software enhancements to the Food and Drug Administration (FDA) in 2015 that the company claims “effectively address the issue” at stake in the Alere recall. The FDA felt otherwise.
In a communication with Alere, the FDA said it doesn’t believe the company’s studies “adequately demonstrate the effectiveness of the software modification,” according to the company statement. The FDA further advised Alere to submit a plan to voluntarily remove the Alere INRatio device from the market.
This is not the first time we have seen an Alere recall concerning the INRatio home monitoring system. In April of 2014, Alere issued a warning that patients with certain medical conditions should not use several Alere INRatio2 PT/INR test strips because patients were given therapeutic INR ratings when, in fact, patients had higher INR readings when tested by a laboratory.
In December of 2014, Alere issued yet another recall for patients with certain medical conditions. This Alere recall was also based on INRatio inaccuracy concerns.
Why the Alere Recall is Important
The Alere INRatio and Alere INRatio2 are portable monitoring systems that can be used by doctors and patients for anticoagulation management. Individuals taking blood thinners like Coumadin, Jantoven, Lovenox (enoxaparin), Pradoxa (dabigatran), Warfilone (warfarin) or Xarelto (rivaoxaban) use home monitoring systems in order to monitor their blood levels at home or at a doctor’s office instead of going to a laboratory. A doctor can adjust a patient’s dosage of blood thinning medication in accordance with these readings.
For people with certain types of medical conditions, a false INR reading could lead to serious health risks. Studies on Alere home monitoring devices have shown that INR readings from Alere test strips can be 3.1 to 12.2 units lower than results from a laboratory when tests were performed within one hour to one day of one another.
These inaccuracies can produce a number of serious medical complications, including subdural hematoma, stroke or other bleeding events. In a number of cases, hematoma death has been reported after individuals mistakenly believed their INR levels were safe, when, in fact, their INR levels were dangerously high.
Alere INRatio Lawsuit
More and more people harmed by Alere home monitoring inaccuracies are making the decision to file an Alere INRatio lawsuit. If you would like to speak with an Alere INRatio lawyer about filing a claim, please contact the law firm of Baum, Hedlund, Aristei & Goldman today for a free, no-obligation case evaluation.