As is common with many defective drugs or devices that are later recalled, the Alere INRatio Monitors and Testing Strips gained their FDA approval through the FDA’s controversial 510(k) program. The program, which has been around for more than 35 years, allows medical device manufacturers like Alere to get their products approved quickly if they…
Although Alere INRatio devices and Testing Strips were recalled in 2014, Alere had knowledge of the dangerous inaccuracies of their devices for more than 10 years. In 2005 and 2006, the FDA issued warning letters to Hemosense, the manufacturer of the INRatio device at that time. In their warning letters, the FDA noted that Hemosense…
Alere INRatio Monitors and Test Strips were recalled in December of 2014 for producing inaccurate test results when compared to laboratory testing. Patients taking blood thinners such as warfarin need to constantly monitor their blood clotting to make sure they do not suffer a serious bleed. Inaccurate readings caused by Alere INRatio products could cause…
In fall of 2015, Bayer and Johnson and Johnson notified the FDA that the device used in the clinical trials for their drug Xarelto (a blood thinner and direct competitor to warfarin) was recalled for giving inaccurate results. The device in question? The Alere INRatio. The clinical trial for the blockbuster blood thinner Xarelto (called…
On December 5th, 2014, medical device manufacturer Alere issued a voluntary recall of their Alere INRatio, INRatio 2PT/INR System and INRatio Test Strips because they can give a false (low) reading. INRatio products are used by people on blood thinners, who must constantly monitor their anti-coagulation levels. If a person who is on blood thinners…
A traumatic brain injury (TBI) can change a person’s life forever. Unlike many other bodily injuries in which a person can heal and return to normal, a person who experienced a TBI may never be the same. While TBI’s can be caused by many different events, some more common events include falls, car accidents, violence,…
Every year in the United States, more than 120,000 children are born with a birth defect. The Centers for Disease Control has found that birth defects are the leading cause of death in infants, with 1 out of 5 infant deaths being caused by a birth defect. While some birth defect causes are known and…
Burns are one of the most common household injuries, especially among children. While many people are aware of the three (technically 4) levels of burn injuries that can occur when a person is burned, many people are probably not aware of the fact that serious burn injuries could lead to permanent disability, and even death…
Every year, an estimated 33,000 accidents and 500 motorist deaths are caused by defective tires. Unfortunately, many of those accidents could have been prevented if the drivers had known that the tires they were relying on were defective. Unfortunately, even in 2016, there is no way to reliably know if your tires are recalled unless…
In 2014, more than 848 million travelers chose to travel by plane rather than other methods. This is a huge number, but one can shrink that number quickly by pointing out the fact that many people we know and love were probably included in those 848 million. Taking this into account, preliminary statistics from the…
