Pharmacy Services Alerts
Roche CoaguChek XS PT Test Strips - Recall Due to Inaccurate International Normalized Ratio (INR) Test Results
Nov 6, 2018 10:15 AM
Roche Diagnostics has recalled 43 lots of CoaguChek XS PT test strips to the patient level (Class I recall). The affected strips have a recalibration defect that affects the accuracy of the results. Since Roche recalibrated the CoaguChek XS PT test strips to the new International Normalized Ratio (INR) standard in January 2018, they have received reports of abnormally high and inaccurate INR test results. The affected products were distributed between January 12 and October 29, 2018, and are used with the following meter devices:
- CoaguCheck XS Plus
- CoaguChek XS Pro
- CoaguCheck XS Professional
- CoaguChek XS PST
- CoaguChek Vantus
The defective test strips may report higher than actual INR, which can lead to inaccurate dosing of warfarin. Roche plans to provide new batches of test strips, recalibrated based on the international standard, to customers by the end of November. To receive replacement products, healthcare providers can contact Roche and patients can contact their self-testing service provider. Customers can visit the manufacturer’s website at http://www.coaguchek-usa.com/coaguchek_hcp/en_US/home.html to see if they have one of the recalled lot numbers.
Customers should stop using and discard the affected test strips, and should not rely on the affected test strips to monitor their INR. Patients with the affected test strips should contact their healthcare provider and have their INR measured by a laboratory test or an alternate meter. Healthcare providers and patients can call Roche Diagnostics 1-800-428-4674 for additional details about this recall.
See the links below for additional information and detailed instructions for patients and healthcare providers, as well as instructions on how to replace defective test strips.
- MedWatch Alert -
- FDA Press Release
- Roche CoaguChek website with a list of recalled lot numbers and instructions for returning defected product –