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Alere INRatio® Test Strips, Monitor System Recalled

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If you have been taking a blood-thinning drug (such as warfarin/Coumadin) or have been receiving heparin injections, you should be aware of an urgent recall of INRatio® PT/INR test strips and monitors. These products are used to test a patient’s INR (international normalized ratio) when taking warfarin and other anticoagulation medications. The goal with warfarin therapy is to maintain a balance between preventing clots and causing excessive bleeding. This balance requires careful monitoring, typically by PT/INR.

According to the FDA, because the affected Alere INRatio® devices inaccurately measure a person’s PT/INR, use of the products may cause serious bleeding events—including death.

What Medical Issues are Associated with Using the Alere INRatio® Monitoring System

In April 2014, the FDA published urgent recall information on INRatio®2 PT/INR Professional Test Strips (PN 99008G2), because patients were receiving inaccurate INR readings. Specifically, patients were receiving readings of therapeutic or near-therapeutic INR. Testing at central laboratories, however, showed significantly higher INR  than what the test strips presented. In May 2014, Forbes reported the strips read anywhere between 3.1 to 12.2 units lower than clinical laboratory results, when tested within one hour to one day of each other. In December 2014, the FDA published urgent recall information on additional INRatio® products, stating Alere admitted to receiving 18,924 complaints of incidents in which the device malfunctioned from 2013-2014. The FDA warned use of the affected devices “may delay treatment and cause severe or life-threatening injuries, including death.”

Given the different test results between the INRatio® devices and clinical laboratory tests, the FDA published notice warning that certain INRatio® products may measure a patient’s INR inaccurately. As a result, patients may be at risk for spontaneous bleeding.

Has the FDA Issued Warnings or Recalls on the Alere INRatio Monitoring System

In April 2014, the FDA published Class 1 recall information—the most serious type of recall—on the INRatio®2 test strips. Alere recalled the test strips after receiving 9 reports of device malfunctions, including adverse injuries and 3 deaths associated with spontaneous bleeding. In December 2014, the FDA published a new Class 1 recall which included additional INRatio monitors and test strips. Since then, the FDA has continued to report on the adverse health issues associated with using these products. The FDA’s most recent urgent recall notice is available online.

 What is the Alere INRatio Monitoring System

According to the company’s website, the Alere INRatio®/INRatio®2 PT/INR Monitoring Systems are handheld blood coagulation systems used to monitor a patient’s blood clotting time—or PT/INR values—while taking warfarin. Routine measurements of PT/INR while on warfarin therapy are necessary to maintain a balance between preventing clots and causing excessive bleeding. Used by healthcare professionals and patients at home, the INRatio® Monitoring Systems consist of a small monitor and disposable test strips.

 

Who Might be Affected

If you or a loved one are taking the anticoagulant (blood-thinning) drug warfarin, check the brand of your PT/INR test strips and monitoring system. The affected products are as follows:

 April 16, 2014 Recall

Product

Ref #

Product   Description

INRatio®2 Test Strip 99008G2 Alere INRatio®2 PT/INR Professional Test   Strip

(Source)

 

December 5, 2014 Recall

Product

Ref #

Product Description

INRatio® Test Strips 0100071 Alere INRatio® PT/INR Test Strips, Box of   12
  0100139 Alere INRatio® PT/INR Test Strips, Box of   48
     
INRatio® Monitors 0100004 Alere INRatio® PT/INR System Professional
  0100007 INRatio® Prothrombin Time (PT) Monitoring   System
     
INRatio®2 Monitors 0200431 Alere INRatio®2 PT/INR Professional   Testing System
  0200432 Alere INRatio®2 PT/INR Home Monitoring   System
  55128A Alere INRatio®2 PT/INR Professional   Monitoring System
  55130 Alere INRatio®2 PT/INR Monitor

(Source)

 

Patients who might be using the drug and the INRatio® Monitoring System include people who have undergone replacement or mechanical heart valve surgery, have irregular heartbeats such as atrial fibrillation, or have had heart attacks. Other types of patients who might be using the INRatio® Monitoring System include those who have, or are trying to prevent, blood clots in veins or in the lungs (pulmonary embolism).

Contact Schlichter Bogard & Denton for a Free Consultation

Attorneys at Schlichter, Bogard & Denton, LLP are investigating potential claims related to this dangerous defect.

The Pharmaceutical Litigation Department at Schlichter, Bogard & Denton, LLP represents clients nationwide who have suffered serious and fatal injuries as a result of dangerous pharmaceutical devices. At Schlichter, Bogard & Denton, LLP, we are committed to protecting the rights of persons injured by pharmaceutical companies.

The attorneys at Schlichter, Bogard & Denton, LLP are offering a free and confidential case review with no further obligation to those who have suffered injuries after using Alere INRatio Monitoring System and Test Strips. If you suffered injuries after using Alere INRatio, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.

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