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 the 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 conducting by Roche; which is still in effect, involving more than 1.1 million packages of CoaguChek XS PT Test Strips that are distributing nationwide from Jan. 12, 2018 to Oct. 29, 2018. The CoaguChek XS PT Test Strips announcing in today’s recall is manufacturing by Roche; but distributing 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.
source and imported
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 continues to sell these test strips in the U.S. even though domestic sales are been stoppe due to safety concerns. To reduce risks to patients; are warning health care providers and the public about the dangers associating with this product;” said FDA Commissioner Scott Gottlieb; M.D. “Distributing products that are not label or authorizing 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 finishing.
Their 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 is prescribing 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 measuring by a blood test to check the International Normalized Ratio or INR. This test is performing by an accredite laboratory on blood draw from a vein or with a fingerstick blood draw using an INR test meter at home or in a doctor’s office.