FDA adds information about warfarin INR test meters to FDA.gov

On February 12, 2018 the FDA added new information about warfarin INR test meters for patients and caregivers using INR test meters in the home and for health care providers using INR test meters in a clinical setting. The FDA has received Medical Device Reporting (MDRs) of adverse events about INR test meters that may have generated inaccurate results, and is providing this information to help patients, caregivers, and health care providers use these devices safely and effectively.

An INR test meter is a portable, battery-operated meter, used to monitor patient response to warfarin. Warfarin (also known by the brand names Coumadin and Jantoven) is a blood thinner prescribed to prevent and treat blood clots, which must be monitored to ensure it is working effectively and being used safely.

Updates to the website include: 

• Tips for patients and caregivers using INR test meters, such as how to take blood from a fingerstick, and how to make sure the meter is working properly
• Information for health care providers, such as medical conditions that could affect test results, and recommendations for confirming test results
• How to report problems with INR test meters

If you have general questions about this information, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.