Class I Recall of Roche Diagnostics CoaguChek XS PT Test Strips

PUBLISHED: Nov 2, 2018
Relevant to: Ambulatory Care, Clinical Lab, Critical Access Hospitals, Home Health, Hospice, Hospitals, Long Term Care, Medical Office, Pharmacy, Rural Health Clinics

Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, is recalling the CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. Roche re-calibrated the CoaguChek XS PT Test Strips in January 2018 to correspond to a newly released INR International Standard. Since this re-calibration, Roche Diagnostics has received reports of patients experiencing abnormally high or inaccurate INR test results when testing with the affected CoaguChek XS PT Test Strips listed in the table below.

Use of affected products may increase the risk of serious adverse health consequences, including death.

Recalled Product Details:

  • Name and Version: CoaguChek XS PT Test Strips
  • Lot numbers: 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
  • Models: CoaguChek XS PT Test 2x24 Strips, CoaguChek XS PT Test 6 Strips, CoaguChek XS Test 24 Tests USA
  • Manufacturing and Distribution Dates: January 12, 2018 – October 29, 2018
  • Devices Recalled in the U.S.: More than 1.1 million packages

The lot number is printed on the test strip label, which is applied to the test strip box and the test strip vial.

According to the recall notice, all patients who have been prescribed the blood thinner warfarin (also known by the brand names Coumadin and Jantoven) to prevent and treat blood clots are at risk of being affected by this recall. Patients with the following conditions are at especially high risk for serious events associated with inaccurate INR measurements:

  • Mechanical heart valve
  • Atrial fibrillation and high-risk CHA2DS2-VASc scores
  • Recent thromboembolic events

Recommendations:

  • Patients and health care providers should switch to new batches of test strips that are calibrated to the previous international standard, which Roche Diagnostics will provide to customers within one month.
    • Patients should also contact their patient self-testing service providers to find out when they will be receiving corrected test strips
  • Patients who are using CoaguChek meters and CoaguChek XS PT Test Strips affected by the recall should contact their health care provider and patient self-testing service providers immediately to determine alternative test methods and address questions regarding their testing schedule.
  • Patients should consult with their health care provider before making any changes to their warfarin dose.

Health care providers and patients with questions may contact Roche Diagnostics at 1-800-428-4674 to learn more details about the recall.

Want to read the full alert and receive alert emails?

Browse Additional Alerts