Warfarin tablets
The U.S. Food and Drug Administration (FDA) announced a Class I recall of test strips used with medical devices that monitor warfarin levels, which means use of these strips may cause serious injuries or death.
Roche Diagnostics has recalled certain test strip lots used with its CoaguChek test meter devices.
The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from January 12, 2018, to October 29, 2018.
The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices.
The FDA said patients and healthcare professionals should not rely on these test meter devices to monitor warfarin levels if they’re using test strips affected by the recall. Instead, patients should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.
“These strips are widely used, and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
“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.”
The FDA’s warning concerning the CoaguChek XS PT Test Strips is based on medical device reports submitted by Roche Diagnostics indicating that the test strips may provide results that are higher than the actual international normalized ratio (INR).
As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk of thrombosis.
Approximately 90 medical device reports and two serious patient injuries involving strokes were reported to the FDA.
Roche Diagnostics attributes the cause of the problem to a recent recalibration of the test strips to a different international standard.
The company plans to provide new batches of recalibrated test strips, based on the previous international standard, to their customers by the end of November.
The FDA reviewed validation data submitted by the company for these recalibrated strips.
Patients who are using CoaguChek meters should contact their healthcare provider to get information about alternative test methods and to address questions regarding their individual testing schedule. Patients should also contact their self-testing service providers to find out when they will be getting their corrected test strips.
For questions about the recall or to report adverse reactions or quality problems, contact Roche Diagnostics Point of Care Technical Service at 1-800-428-4674.
Adverse reactions can also be reported to the FDA through MedWatch, the agency’s voluntary reporting program.