This article has been updated with a comment from Roche.
NEW YORK (360Dx) – Roche has voluntarily recalled its CoaguChek XS PT test strips for monitoring patient response to the blood thinner warfarin, according to the US Food and Drug Administration.
The recall affects certain lot numbers and package sizes that were manufactured and distributed between January 12 and October 29 of this year and involves more than 1.1 million packages.
The test strips are used with Roche INR test meters — including the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus devices — to monitor patient response to warfarin.
A drop of blood from a fingerstick blood draw is added to the test strip and the meter measures how long it takes the blood to clot using a standardized calculation called INR (International Normalized Ratio). The result is used to determine whether warfarin dosing is appropriate.
Roche recalibrated the test strips in January to correspond to a newly released INR international standard. Since then, it has received reports of patients experiencing abnormally high INR test results, making the recall necessary.
Following the incorrect INR results, some patients may have been prescribed an insufficient warfarin dose, or asked to interrupt warfarin use, increasing their risk for blood clots. The FDA said it received 90 medical device reports and two serious patient injuries involving strokes.
Roche said patients and healthcare providers should switch to new batches of test strips that are calibrated to the previous international standard, which it will provide to customers within a month.
The FDA said this is a Class I recall, the most serious type, since the use of the faulty strips may result in serious injuries or death.
The agency warned patients and healthcare professionals to stop using Roche's meters with test strips affected by the recall and to have blood drawn and analyzed by a laboratory test or an alternative meter device, instead.
"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," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in a statement.
According to a Roche spokesperson, the company began reviewing data, patient reports, and other information as soon as it was informed about the innaccurately high INR test results and issued a voluntary Urgent Medical Device Correction to its customers, providing instructions for confirmatory testing.
"We’re now taking additional action by proactively replacing all affected test strips in the market" and by instructing healthcare providers and patients to stop using them, the spokesperson said. Roche has started shipping newly calibrated test strips and is hoping to have all affected test strips replaced by the end of November.