The FDA recently warned patients and doctors about the use of medical devices to monitor levels of the blood thinner warfarin. The FDA recalled some test strips that are used with the devices after discovering that they may provide inaccurate results and should not be relied upon.
Roche Diagnostics voluntarily issued a recall of certain test strip lots that are used with its CoaguChek test meter devices. Over 1.1 million packages of CoaguChek XS PT Test Strips that were distributed between January and October of this year were recalled. This recall was announced as a Class I recall, which is the most serious type of recall, meaning that the use of these devices could cause serious injuries or death.
The FDA is warning patients and health care professionals that they should not rely on the test meter devices to monitor warfarin levels if they are using test strips that are affected by the recall. Instead, those patients should have blood drawn from a vein and have that blood analyzed by an alternative device.
The drug warfarin is used by millions of Americans to both prevent and treat blood clots. It is prescribed for people with irregular heartbeats, blood clots, and device implants such as heart valves. For those patients, it is critical to get the correct dosage of warfarin. The patients must be monitored to test how long it takes their blood to clot. That test can be done at home using an INR test meter. The recall is because some test strips may provide results that are higher than the actual INR. If INR results are incorrect, patients at an increased risk of blood clots may be at higher risks of health problems as a result.If you or a loved one has been harmed by a medical device, you should speak with an attorney. You may have the legal right to compensation. Call the Houston medical device attorneys at Kennedy Hodges at 855-947-0707. We can help. Call us today to learn more or to schedule a free consultation, or visit us on Google Plus.