Medical Devices

Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death

Recalled Product:

  • 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.

Image showing the location of the lot number on the test strip vial label.

Device Use

CoaguChek XS PT Test Strips are used with Roche INR Test Meters to monitor patient response to warfarin, a blood thinner prescribed to prevent and treat blood clots. The test strip is inserted into the test meter, and then a medical pricking needle (a lancet) is used to obtain blood which is applied to the test strip. The meter reads the test strip, measures how long it takes the blood to clot, and provides the result based on a standardized calculation in the form of the International Normalized Ratio, or INR. The INR is used by patients and physicians to determine if warfarin dosing is appropriate.

Image of CoaguChek XS PT Test Strips box

Reason for Recall

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.

Who May be Affected

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.

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

What to Do

  • 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.

Contact Information

Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46250-1025
1-800-428-4674

Full List of Affected Devices
ProductCatalog NumbersAffected Lot Numbers
CoaguChek XS PT Test 2x24 Strips
04625315160
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
CoaguChek XS PT Test 6 Strips
04625374160
CoaguChek XS Test 24 Tests USA
07797826160

Date Recall Initiated:

September 13, 2018

Additional Resources:

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

Page Last Updated: 11/01/2018
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