NOVEMBER 2, 2018:
A new MedWatch Safety Alert recall: CoaguChek XS PT Test Strips by Roche Diagnostics: Due to Inaccurate INR Test Results was just added to the FDA Medical Device Recalls webpage. This is an important recall as so many home health agencies perform in-home INR testing.
Nurses need to check their test strips and make sure they are not using the ones for testing that have been recalled. The FDA has identified this as a Class I recall, the most serious type of recall. This recall only applies to Manufacturing and Distribution Dates between January 12, 2018 – October 29, 2018. The web page below provides the details of the lot numbers. You can copy and paste this link, and read the complete recall at: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm624822.htm