Class I recall for over 1.1 million packages of CoaguChek XS PT strips
A massive Class I recall is underway for Roche Diagnostics' CoaguCheck XS PT test strips used with point-of-care and home devices to adjust warfarin dosing, the FDA said.
The test strips may overstate patients' actual International Normalized Ratio (INR), leading to underdosing or interruption in warfarin use.
Since Roche recalibrated the test strips in January 2018 to correspond to a newly released INR International Standard, the FDA has received about 90 medical device reports. Two serious patient injuries involving strokes have been reported to the agency.
An estimated 1.1 million packages are affected by the recall of the test strips, which are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices.
"These strips are widely used and we are working diligently to warn health care 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," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in a press release from the agency. "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 health care providers as quickly as possible."
Roche Diagnostics should have new batches of test strips calibrated to the previous international standard to customers by the end of November, according to the FDA, which said it had reviewed the validation data for the recalibration.
The FDA recommended that patients immediately talk to their physician about alternative test methods -- levels measured by laboratory tests using blood draws or an alternative meter device -- and contact their patient self-testing service providers to find out when they will be getting their corrected test strips.
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Read the original article on Medpage Today: Warfarin INR Test Strips Recalled