Alere INRatio Recall: Blood Clot Monitoring System Lawsuits and Settlements

Have you been injured using the Alere INRatio blood clot monitoring system? If so, you may be entitled to compensation.

The Alere INRatio recall was issued by the FDA because the blood clot monitoring systems were shown to deliver incorrect test results. This is a Class 1 recall, the most serious classification issued by the FDA for medical device product failures because inaccurate INR test levels could result in serious injury or death.

The recall affects Alere’s INRatio and INRatio2 PT/INR Monitoring Systems including:

  • 125,576 test strip kits (12 count),
  • 24,783 test strip kits (48 count), and,
  • 236,345 INRatio or INRatio2 monitors.*

* See below for a complete list of recalled devices

The Alere patient INR tests measure blood coagulation activity. If the blood clot factor (INR level), is too low, a patient could suffer excess bleeding. If it is too high there is a risk of blood clot formation (thrombosis) that could block the circulatory system. The recalled test kits are known to have delivered inaccurate results putting patients at risk for serious injury or death including, among other conditions, subdural hematoma, hemorrhagic stroke, uncontrollable bleeding, organ damage, or a related injury.

If you or someone in your family has used one or more of the devices affected by the Alere INRatio recall to test and control anticoagulation (blood clot) therapy you should consult your doctor immediately. It is important that you request a new blood test for anticoagulation clotting factors to make sure your results are normal. You should also seek out legal counsel to protect your interests in the event you have, or may suffer an injury from use of the recalled Alere test kits or monitors.

Stark & Stark attorneys are actively seeking and filing legal claims for those injured or killed from use of recalled Alere INRatio test kits, and INRatio2 PT/INR Monitoring Systems. Please contact your doctor first to get retested, and then contact Stark & Stark for assistance.

What is wrong with the Alere INRatio Testing Devices?


Alere INRatio test strips and monitors measure a patient’s International Normalized Ratio (INR) which is the blood factor that shows how quickly your blood clots. The devices are generally prescribed for patients taking Coumadin (warfarin) or other blood thinning medications. The tests are necessary to maintain normal blood clotting activity in affected patients. Depending on the test results, medication dosage is changed to normalize the results. The thinner your blood, the longer it takes to clot, the higher your INR value. The thicker your blood, the faster it clots, the lower your INR value. High INR can lead to uncontrollable bleeding, while low INR can lead to a risk of blood clot or stroke.

Device Failures

Under certain conditions, the Alere INRatio and INRatio2 PT/INR Monitoring Systems were found to generate inaccurately low INR readings. Simply stated, the systems were inaccurately reading INR levels in patients, which resulted in dangerously inaccurate dosage changes, which put patients at a high risk for potentially deadly bleeding events. Essentially the revised or continued medication dosage was thinning already thin blood to dangerous levels.

Alere INRatio Recall List

Based on thousands of patient complaints of injuries (including cranial bleeding, stroke and death), all of the following Alere INRatio and INRatio2 PT/INR Monitoring System monitors and test strips manufactured and distributed from April 1, 2008 to July 8, 2016, were recalled:

  • Alere INRatio2 PT/INR Professional Monitoring System (55128A)
  • Alere INRatio2 PT/INR Home Monitoring System (0200432)
  • Alere INRatio2 Replacement Monitor (Home) (0200457)
  • Alere INRatio2 PT/INR Professional Testing System (0200431)
  • Alere INRatio/INRatio2 PT/INR Test Strips (99007EU, 99007G1, 99007G3,99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5,99008G7)
  • Alere INRatio PT/INR System Professional (0100004)
  • Alere INRatio Prothrombin Time (PT) Monitoring System (0100007)
  • Alere INRatio Replacement Monitor (0100137)
  • Alere INRatio PT/INR Test Strips (0100071, 0100139)

Do I have a claim related to use of the Alere INRatio recalled products?

You may have a claim if you or someone in your family used one or more of these devices during the recall years of 2008-2016 and suffered an unexpected injury or deadly bleeding event.

Stark & Stark attorneys are actively negotiating Alere INRatio and INRatio2 PT/INR Monitoring System settlements and evaluating claims for Alere INRatio and INRatio2 PT/INR Monitoring System lawsuits on behalf of patients injured or killed from use of the potentially defective devices. We are committed to holding drug and medical device manufacturers liable when their products improperly endanger the public and put patients at a high risk of injury or death.

Our Alere INRatio and INRatio2 PT/INR Monitoring System lawyers are experienced in medical device and pharmaceutical product failure negotiating strategies that get the best results for our clients.

If you or someone in your family has been affected by the INRatio recall, you should contact us to assess your eligibility for a claim against the manufacturers of the Alere INRatio test kits and monitors and to help you understand the Alere INRatio and INRatio2 PT/INR Monitoring System lawsuit and potential settlement process.

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