Recall Z-0360-2019 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Corporation
CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
| Date | Nov 2, 2018 (initiated Sep 13, 2018) |
| Status | Terminated |
| Reason | Abnormally high INR test results with the affected CoaguChek test strips |
| Root cause | Nonconforming Material/Component |
| Action | Roche issued URGENT MEDICAL DEVICE RECALL AMENDMENT letters dated 11/5/18 advising customers patients, HCPs, IDTFs, HCP distributors and HCP/patient distributors. Distributors are advised to take the following actions: - Read the Urgent Medical Device Recall Amendment for Healthcare Professionals and Clinics Furnishing PT/INR Test Strips to Patients for Home Testing Use (TP-00454). - Distribute a copy of the Urgent Medical Device Recall Amendment TP-00454 to healthcare professionals to whom you have directly shipped affected test strips. - Stop distribution of all affected CoaguChek XS PT Tes |
| Quantity | 1,163,952 boxes |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |