The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices.
Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The FDA said today that the devices should not be used to adjust drug dosages.
The recall involves more than 1.1 million packages of the CoaguChek XS PT test strips that were distributed across the U.S. between Jan. 12 and Oct. 29.
A Class I recall is the most serious type of recall and indicates that the use of the affected devices could cause serious injuries or death.
Roughly 90 medical device reports and two serious patient injuries involving strokes have been reported to the FDA involving the CoaguChek XS PT test strips.
Roche Diagnostics told the FDA that the cause of the problem is a recent re-calibration of the test strips to a different international standard. The company plans to give new batches of re-calibrated test strips to its customers by the end of this month.
“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,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in prepared remarks.
“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,” Shuren added.
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