INR Test Strips Recalled Due to Inaccurate Measurements

Roche Diagnostics has recalled more than 1.1 million packages of its CoaguChek XS PT test strips, which are used for monitoring international normalized ratio (INR) in patients taking warfarin. The US Food and Drug Administration (FDA) announced the action as a class I recall, the most serious type, on Thursday.

The manufacturer first reported an issue with strips providing abnormally high or inaccurate test results after being recalibrated to a new international standard in a letter to healthcare professionals dated September 12; the recall was initiated the following day.

According to an FDA press release, the agency has received about 90 reports related to the issue, including two that described serious patient injuries due to strokes.

“These strips are widely used and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall. Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “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.”

Affected lot numbers—which are printed on the test strip label—can be found on the FDA website. The recall covers the following CoaguChek XS PT Test models distributed between January 12 and October 29 of this year: 2x24 strips, 6 strips, and 24 tests USA.

The FDA said users of the recalled strips should switch to other products calibrated to the previous international standard until Roche Diagnostics can provide new strips, which is expected by the end of November.

Photo Credit: CoaguChek