Warfarin test strip recall declared Class I by FDA

The FDA announced it has declared a recall of warfarin test strips as Class I, the most serious kind.

Medical product distributor Terrific Care/Medex Supply LLC issued a voluntary recall of certain Roche Diagnostics test strip lots used with CoaguCheck test meter devices in December. The FDA in a press release stated it declared the recall as Class I due to risk for serious injuries or death. According to the agency, the test strips may provide inaccurate results and prove unreliable when considering adjusting a patient’s warfarin dose.

In November, Roche Diagnostics recalled more than 1 million packages of its CoaguChek XS PT test strips distributed in the United States from Jan. 12 to Oct. 29, 2018.

The test strips in the recall were manufactured by Roche, but distributed by Terrific Care/Medex Supply and were not for sale in the U.S.

Terrific Care/Medex Supply purchased the test strips from an unknown source and imported and sold the products in the U.S., according to the release from the FDA.

“Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots,” FDA Commissioner Scott Gottlieb, MD, said in the release. “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 distribute continued to sell these test trips in the U.S. even though domestic sales had been stopped due to safety concerns.”

The FDA recommends patients should have their warfarin levels measured by a laboratory test or an alternative meter device should be used.