Alere Blood Clot
Monitoring Systems

The Alere INRatio monitoring device is used by patients who are at an increased risk for blood clots and as a result, take blood-thinning medication to reduce that risk. The device is used by patients at home, often in lieu of laboratory testing, to monitor INR levels which indicate whether the blood is flowing at a healthy thickness. Practitioners rely on the INR level in prescribing the correct amount of blood thinning medication.

Recently, the makers of the Alere INRatio device issued a product-wide recall, citing that the machine could generate artificially low INR levels. The generation of inaccurate INR levels can result in the prescription of too much or too little blood thinning medication which causes life-threatening, severe internal bleeding.

Case Quick Facts

The Problem

According to the recall notice issued on August 19, 2016, there have been reports that the Alere INRatio monitoring device has generated artificially low INR readings. Such a reading could result in an overdose of the anti-clot medication, causing severe internal bleeding.

Public Citizen, a consumer advocacy organization, has analyzed the Manufacturer and User Facility Device Experience (MAUDE) Database and found 9,469 malfunction reports and 1,445 injury reports to the FDA from January 2002 to November 2015.

The Injuries

When INR readings are inaccurate, patients may be overdosed with Warfarin, putting their health and life at stake. As a result of these inaccurate readings, patients have experienced catastrophic injuries such as:

  • Hemorrhagic stroke
  • Subdural hematoma
  • Excessive bleeding requiring hospitalization
  • Death following a hematoma
The Defendant(s)

The defendant in this case is Alere.

GoldenbergLaw Can Help

The litigation status on this case is active. Our Alere INRatio lawsuit lawyers will listen to your case and determine what we can do for you.

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What is the Alere INRatio?

The Alere INRatio and INRatio2 are portable blood clot monitoring systems designed for both professional and patient use. There are two main parts to the systems – the monitor (similar in size and design to an insulin pump monitor) that reads the results and the strips that collect the patient’s blood. These systems are quicker, cheaper, and easier than the gold-standard laboratory tests and allow patients to test their blood clotting levels at home.

How Does it Work?

The INRatio and INRatio2 systems measure the clotting abilities of your blood by calculating the blood INR level. The devices are often used by patients at home, in lieu of the gold-standard laboratory testing. The test results are then used by doctors to determine the correct amount of blood thinning medication to prescribe to the patient. In normal adults an INR of roughly 1 is considered to be healthy. In those utilizing a blood thinner an INR between 2 and 3 is healthy. A low INR corresponds with a high clotting ability, which could lead to blood clots. A high INR means that your blood is not clotting quickly enough and could lead to a hemorrhagic event.

Product Recalls

Class II recall – November 5, 2005

The recall dealt with a software problem that may have caused the INRatio meter to incorrectly display “INR>7.5” test message under a particular use condition. The recall affected 123 units.

Product Recalls

Class II recall – November 16, 2011

Alere initiated a recall of the Professional Disposables International (PDI) alcohol prep products because of the potential presence of the toxin Bacillus cereus.

Product Recalls

Class I recall – January 3, 2015

In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.

Product Recalls

Class I recall – August 19, 2016

On August 19, 2016 Alere issued a voluntary Class I recall for over 230,000 Alere INRatio/INRatio2 PT/INR Monitoring Systems (both test strips and meters). As of August 25, Alere has notified consumers that it will be discontinuing the product line because it has been unable to make adequate modifications to ensure the safety and effectiveness of its systems.

Why Choose GoldenbergLaw?

Since the recall, many people have come out with lawsuits against Alere and the INRatio test strips. If you find yourself involved in an Alere INRatio lawsuit, contact GoldenbergLaw today. GoldenbergLaw has an experienced team of Alere INRatio lawyers to make sure you and your family are taken care of in the event of medical issues related to the Alere INRatio recall.

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