Yet another recall has been made on the heels of serious and traumatic device malfunctions- nearly 19,000 reports, to be exact. The recall for Alere INRatio and INRatio2 by the Food and Drug Administration has been upgraded to a Class I recall, meaning use of the product could cause serious or adverse health consequences and even death.
The recall in 2014 came because the Alere INRatio and INRatio2 provided falsely low international normalized ratio (INR) levels in patients on blood thinners. Because certain blood thinners block vitamin K, the medicines prevent blood clots from forming; however, depending on the results of an INR test, patients could take the wrong dosage of a blood thinner and therefore be at a greater risk of blood loss and death.
Patients who used the recalled Alere INRatio products, as opposed to a centralized laboratory plasma INR test, could have received readings anywhere from 3.1 to 12.2 units lower, a misreading that could cause serious medical problems.
The Alere INRatio and INRatio2 monitor systems and test strips are used to monitor blood-clotting time while the patient is on warfarin therapy. Anticoagulant medicines, such as warfarin, are used in patients who have had heart valve surgery, heart attacks, have an irregular heartbeat, or are trying to prevent deep vein thrombosis (blood clots deep within the body) and pulmonary embolisms (blood clots in the lungs).
In a letter sent to patients using the Alere INRatio products, the manufacturer explained that certain cases of patients using the product could provide results that are “significantly lower than a result obtained using a laboratory INR system…” and that the issues can arise if the patient has certain medical conditions such as anemia, bleeding or unusual bruising, or any condition associated with elevated fibrinogen (the protein from which a blood clot is formed) levels.
The recall came after nearly 19,000 patients reported device malfunction. Alere acknowledged receiving “serious adverse event reports,” admitting some “described bleeding associated with patient deaths.”
Levin Papantonio attorney Ned McWilliams has been working on the Alere INRatio lawsuits and is determined to bring justice to those affected by this recall. “For the company to allow literally tens of thousands of reports of malfunction before taking action is grossly negligent, if not criminal,” said McWilliams. “The absolutely critical importance of this device to provide accurate results cannot be overstated.”
Although presently there have been no large group settlements involving the Alere INRatio monitoring systems and test strips recall, time is of the essence for any affected patients to begin the litigation process in order to potentially receive the settlement deserved. There are time restraints to file a claim against this manufacturer. If you or a loved one has experienced potential harm due to the Alere INRatio monitoring systems and test strips, contact a Levin Papantonio attorney before the statute of limitation expires.