Recall Z-0787-2019 ยท GJS Test, Time, Prothrombin
TERRIFIC CARE LLC
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
| Date | Feb 1, 2019 (initiated Dec 20, 2018) |
| Status | Terminated |
| Reason | Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba MedEx Supply via website/telephone/facsimile. |
| Root cause | Nonconforming Material/Component |
| Action | On December 20, 2018, Terrific Care, LLC. / Medex Supply Dist, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter (dated 12/19/18) of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. via website/telephone/facsimile orders. On December 21, 2018, Terrific Care, LLC / Medex Supply Dist, Inc. re-issued an Amended Press Release identifying affected Catalog Numbers and lots. On December 26, 2018, recall notices were issued to customers via email. On or about January 29, 2019, Terrific Care, LLC. / Medex Supply Dist, Inc. re-issue |
| Quantity | 793 boxes |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.