Alere INRatio and INRatio2 Recall

Minneapolis - St. Paul, Twin Cities, Minnesota & Nationwide

Alere INRatio and INRatio2

Alere INRatio blood testing monitors and test strips are not providing accurate readings of a person’s blood clotting ability. These false readings can lead to incorrect doses of Warfarin causing severe bleeding, subdural hematoma, stroke or even death.  According to the FDA, on August 19, 2016, this has finally resulted in the total recall of the product from the market. 

If you or a loved one took Warfarin or other anticoagulation drugs and suffered from a serious injury or death that could have potentially been attributed to inaccurate INR readings from an Alere INRatio blood clot monitoring device or test strip, please contact our firm located in Minneapolis, Minnesota to learn about your legal rights and choices. We have 31 years of national drug and device experience.  We want to help you or your family.

History of INRatio 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.

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.

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.

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.

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 the INRatio work?

The INRatio and INRatio2 systems measure the clotting abilities of your blood using impedance. This means that the device tests the electronic resistance of each blood sample it surveys. Blood enters the sample test strip containing reagents necessary to start the clotting process. Once the blood sample covers the full testing area, the impedance will fall to a minimum. The monitor marks the time as T=0. As the reaction progresses the impedance will rise to a maximum and then drop to a second minimum once the clotting process is completed. From this data the monitor can calculate the INR, or International Normalized Ratio. There are two additional channels that are used by the monitor to test a high and low control.

What is the problem?

The problem with these devices is that they can give inaccurate and false INR readings. The device is meant to describe a patient’s clotting abilities based off of a simple numerical reporting scale. 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. 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. Most of the MAUDE events indicated that the INR was artificially low, but a fair number also reported the opposite.

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 injury such as:

  • Hemorrhagic stroke
  • Excessive bleeding
  • Death

How can GoldenbergLaw help?

If you can say yes to the following criteria, you may have a claim.

  1. Did you use the Alere INRatio or INRatio2 PT/INR Monitor System? OR
  2. Did you use the Alere INRatio or INRatio2 Test Strips?
  3. While using the Alere system or strips, did you or a loved one experience any of the following injuries?
  •   Subdural Hematoma
  •   Hematoma Death
  •   Stroke or Mini-Stroke
  •   Other Serious Bleeding Event requiring hospitalization.

If you have suffered a serious injury due to false readings from the Alere INRatio PT/INR Monitor System or INRatio Test Strips you have the right to seek compensation. There are no costs up-front if you decide to contact our firm. You do not pay us a fee unless we recover compensation for you or your family.

Manufacturers of medical devices have a legal duty to make products that are reasonably safe. For 31 years, GoldenbergLaw has successfully represented thousands of injured people around the country in defective drug and device cases against some of the world’s largest corporations. We have the national experience, the resources and the desire to hold these companies accountable for their actions. We will fight for you to obtain fair compensation for your, pain, disability, medical bills, wage loss and the terrible effect this has had on the quality of your life.

Time is of the Essence

Time is of the essence. There are legal time limitations that may bar your claim. Please contact us for a free case evaluation to understand your rights. You may fill out the form on this page or simply call us toll free at (855) 333-4662.