Test strips used with medical devices that monitor warfarin levels have been recalled by Roche Diagnostics, due to inaccuracies. The recall encompasses 43 lots with more than 1.1 million packages of Roche’s CoaguChek XS PT Test Strips, manufactured from January 12, 2018 to October 29, 2018.1,2

The FDA announced the action as a Class I recall. The most serious type of recall, the Class I designation means that these devices may cause serious injuries or death.1

Also known by the brand names Coumadin and Jantoven, warfarin is a blood thinner used to prevent and treat blood clots. The drug may be prescribed for individuals with certain types of irregular heartbeats, blood clots in the lungs or legs, or certain implanted medical devices, such as artificial heart valves.1

According to the FDA, it is crucial that patients achieve the correct warfarin dosage, and patients need to regularly monitor the length of time it takes their blood to clot. A patient’s International Normalized Ratio (INR) is measured by a testing blood drawn from a vein or with a fingerstick using an INR test meter at home or in a doctor’s office.1

Roche is recalling CoaguChek XS PT Test Strips due to INR test results that were inaccurate when compared to laboratory results. According to the FDA, Roche had recalibrated these test strips in January 2018 to have them correspond to a newly release INR standard. Since recalibrating, Roche has received reports of patients experiencing abnormally high or inaccurate INR test results.1,2

All patients who have been prescribed warfarin may be affected by the recall. Patients with mechanical heart valve, atrial fibrillation and high-risk CHA2DS2-VASc scores, or recent thromboembolic events are at especially high risk for serious events associated with inaccurate INR measurements.2

According to Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, the recalled test strips are widely used. In a prepared statement, he said the FDA is working diligently to warn the public and health care providers about the dangers associated with these products.1

“Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients,” said Shuren, in his statement.1 “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.”

Officials with the FDA warned patients and health care providers that they should not rely on test meter devices to monitor warfarin levels if they are using test strips included in the recall. The FDA recommended that these individuals instead use an alternate device or have blood drawn from a vein and have their warfarin levels checked by a laboratory test.1

The following lot numbers are being recalled:2
  • 28124111
  • 28124121
  • 28631911
  • 28631921
  • 28631924
  • 28632021
  • 28632213
  • 28632312
  • 28632412
  • 29415113
  • 29415123
  • 29494221
  • 29494312
  • 29494613
  • 29494711
  • 29778721
  • 29779012
  • 29779213
  • 29779214
  • 30497213
  • 30497311
  • 30497413
  • 30497423
  • 30497515
  • 31404314
  • 31404821
  • 32264116
  • 32264212
  • 32264316
  • 32264317
  • 32264411
  • 32264421
  • 33045913
  • 33046011
  • 33046113
  • 33046312
  • 33046314
  • 33046321
  • 33046322
  • 33449612
  • 33449712
  • 33449723
  • 33449817
Roche Diagnostics will provide new batches of test strips that are recalibrated to the previous international standard to customers within 1 month, according to the FDA. Patients and health care providers with questions about the recall should contact Roche at 1-800-428-4674.2 

  1. FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin [news release]. Silver Spring, MD; November 1, 2018: FDA website. http://www.pharmacytimes.com/link/229. Accessed November 2, 2018.
  2. Medical device recalls. Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results. FDA website. http://www.pharmacytimes.com/link/230. Updated November 1, 2018. Accessed November 2, 2018.