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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.

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