FDA issues Class I recall for warfarin test strips after patient strokes

The FDA has announced a Class I recall for 1.1 million packages of CoaguChek XS PT test strips used with point-of-care or in-home devices to adjust warfarin dosing.

The recall comes after certain test strips were revealed to overestimate patients’ actual International Normalized Ratio (INR), leading to an underuse of the blood-thinner. About 90 medical device reports and two patient injuries involving strokes have been reported, according to the FDA.

The strips were manufactured by Roche Diagnostics and were distributed nationwide between Jan. 12 and Oct. 29.

“These strips are widely used, and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients. We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and healthcare providers as quickly as possible.”

Millions of Americans take the blood thinner warfarin, and INR is designed to ensure the blood stays in an ideal range of coagulation. With a misleading INR result, some patients may take too little of the medication and be exposed to clot-related events such as stroke.

According to the announcement, Roche attributes the issue to a recent recalibration of the test strips to match a new international INR standard. A separate FDA notice suggested patients and healthcare providers switch to other batches of test strips that are calibrated to the previous standard, which Roche said it would provide to customers by the end of November.

The agency also said patients using CoaguChek test meters should contact a healthcare provider or self-testing service provider immediately to “determine alternative test methods and address questions regarding their testing schedule.” The recalled strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST and CoaguChek Vantus test meter devices.