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FDA Classifies Recall of Blood Thinner Monitoring Tests as Class I

NEW YORK (360Dx) – The US Food and Drug Administration today issued a Class 1 recall classification to a voluntary recall issued last month for certain Roche Diagnostics test strip lots used with the firm's CoaguChek test meter.

A Class I recall, the most serious type, means use of these devices may cause serious injuries or death, the FDA said.

Roche manufactured the CoaguChek XS PT Test Strips announced in today's recall, but Terrific Care/Medex Supply distributed them. The test strips were neither labeled nor authorized for sale in the US and were only distributed by Roche Diagnostics outside the country, the FDA said.

The recall includes catalog numbers not associated with a November 2018 recall by Roche. Terrific Care/Medex Supply purchased the Roche test strips from an unknown source and imported and sold them in the US, the agency added.

The November Roche recall is still in effect and 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.

In a statement today, the agency warned 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."

"Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots," FDA Commissioner Scott Gottlieb said in a statement. "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 US even though domestic sales had been stopped due to safety concerns."

A Roche spokesperson said previously that the company had begun reviewing data, patient reports, and other information as soon as it was informed about inaccurately high INR test results and issued a voluntary Urgent Medical Device Correction to its customers, providing instructions for confirmatory testing.