FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin
The U.S. Food and Drug Administration 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. 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 the 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.
As with the previous recall, the FDA is warning patients and healthcare 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 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 healthcare providers who are using CoaguChek meters should immediately stop using test strips purchased from Terrific Care/Medex Supply and use an alternative test method.
