The FDA has announced a Class I recall on Roche’s CoaguChek XS PT Test Strips that were manufactured from January 12, 2018, to October 29, 2018.
A Class I recall means that the recalled devices could potentially cause severe and fatal injuries. The recall involves 43 lots and more than 1.1 million packages of test strips. The manufacturer of the Caogucheck test strips, Roche Diagnostics, is recalling their products due to inaccurate INR test results. The CoaguCheck XS PT Test Strips were re-calibrated by Roche in January 2018 however, there have been multiple reports of patients experiencing inaccurate or unusually high INR test results when using the defective test strips. The FDA has announced in an online report that anyone using these test strips is subject to an increased risk of severe and fatal health risks, including death.
What Are CoaguChek XS PT Test Strips?
The Prothrombin Time (PT) test is a blood test that lets patients measure the amount of time it will take for a blood clot to form. The CoaguChek XS PT Test Strips can be used to check for bleeding issues and whether or not blood thinning medications are working for a patient. Anyone taking blood thinner medications, or anticoagulants, must be tested regularly to ensure that the International Normalized Ratio (INR) stays within a certain test range. The INR is a term used by professionals for a blood test to find out the amount of warfarin is in a patient during the blood test. Common names for warfarin are Coumadin, Jantoven, and Marfarin.
If a patient is out of range this means that their INR test results are either higher or lower than what the patient’s doctor has set as the patient’s target range. According to the FDA, it is important for patients to have the correct warfarin dosage, and patients need to monitor the length of time it takes their blood to clot.
Who Is Affected By The Recall?
Patients that have been prescribed warfarin, a blood thinner medication that is used to treat and prevent blood clots, are at risk. You are at an extremely high risk of serious health effects if you have the following conditions:
- Recent thromboembolic events
- Atrial fibrillation and high-risk CHA2DS2-VASc scores
- Mechanical heart valve
If you suspect that you were affected by this recall, then do the following:
- Contact your health care provider to learn about changing the warfarin dosage amounts.
- Contact your health care provider and patient self-testing service provider to learn about alternative methods for testing and to adjust testing schedules.
- Contact your self-testing service provider to learn about getting corrected test strips.
- Switch to a new brand of test strips that are calibrated to the international standard.
- Contact an experienced defective medical device lawyer to learn about receiving compensation for any pain and suffering you may have experienced due to this recall.
Warnings From The FDA
Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, says that the recalled CoaguCheck XS PT Test Strips are widely used. In a prepared statement, he said the FDA is working diligently to warn the public and health care providers about the dangers associated with these products. He also said that “using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients,”
The FDA has announced a warning to all patients and health care providers that advises them not to depend on test meter devices to monitor warfarin levels if they’re using any of the test strips that are included in this recall. It was also recommended by the FDA that patients seek out alternative solutions to getting their test results.
Contact KBA Attorneys if you or a loved one has been affected by the CoaguChek XS PT Test Strips recall. Our defective device lawyers have years of combined experience in helping victims of recalled medications and devices receive compensation. Get a free case evaluation today.