FDA warns that some home-use test strips may provide inaccurate results

The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Medical product distributor Terrific Care/Medex Supply LLC issued a voluntary recall of certain Roche Diagnostics test strip lots used with CoaguChek test meter devices last month. Today, the FDA classified this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death. This recall is related to the November 2018 Roche Diagnostics Recall, the manufacturer of CoaguChek meters and test strips.

The previous recall conducted by Roche, which is still in effect, involved more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from Jan. 12, 2018 to Oct. 29, 2018. The CoaguChek XS PT Test Strips announced in today's recall were manufactured by Roche, but distributed by Terrific Care/Medex Supply and include catalog numbers that were not included in the recent Roche recall because these strips were not labeled or authorized for sale in the U.S. and were only distributed by Roche Diagnostics outside the country. Terrific Care/Medex Supply purchased the Roche test strips from an unknown source and imported and sold them in the U.S.

"Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots. Using faulty strips can lead to errors in medication dosage that could cause serious harm or death in some patients. That's why it's so concerning that this distributor continued to sell these test strips in the U.S. even though domestic sales had been stopped due to safety concerns. To reduce risks to patients, we're warning health care providers and the public about the dangers associated with this product," said FDA Commissioner Scott Gottlieb, M.D. "Distributing products that are not labeled or authorized for sale in the United States raises significant concerns for us in view of the serious safety issues with these test strip devices, and our work on this matter is not finished. Our top priority is the immediate safety of patients, and we're taking steps to ensure the products that this company distributed are removed from the market."

As with the previous recall, the FDA is warning patients and health care professionals that they should not rely on these test meter devices to monitor warfarin levels if they're using test strips affected by the recall. Instead, they should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.

Millions of Americans take the blood thinner warfarin (also known by the brand names Coumadin and Jantoven) to prevent and treat blood clots. The drug may be prescribed for patients with certain types of irregular heartbeats, blood clots in the legs or lungs, or certain medical device implants such as artificial heart valves. Achieving the correct warfarin dosage is crucial, and patients need regular monitoring to test how long it takes their blood to clot. The response is measured by a blood test to check the International Normalized Ratio, or INR. This test can be performed by an accredited laboratory on blood drawn from a vein or with a fingerstick blood draw using an INR test meter at home or in a doctor's office.

The FDA's previous warning concerning the CoaguChek XS PT Test Strips was based on medical device reports submitted by Roche Diagnostics to the agency indicating that the test strips may provide results that are higher than the actual INR. As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots.

Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, with atrial fibrillation (irregular heartbeat) who are at a high risk of stroke, or those who had a recent blood clot. It is important to note that problems with the CoaguChek XS PT test strips are not likely to be evident to the patient.

The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST and CoaguChek Vantus test meter devices.

Patients and health care providers who are using CoaguChek meters should immediately stop using test strips purchased from Terrific Care/Medex Supply and use an alternative test method.

All health care providers, patients and caregivers, are strongly encouraged to voluntarily report INR test meter problems directly to the FDA through MedWatch, the FDA's voluntary reporting program. Problems should be reported whenever one suspects that there may be an issue with an INR test meter such as a malfunction or incorrect result, or that the meter caused or contributed to a serious injury or death.

The FDA is committed to continuing to communicate publicly on this issue and will provide updates related to this recall when available.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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