FDA Device recall Z-0787-2019
CoaguChek XS PT Test
- FDA Device
- Class I
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class I recall of CoaguChek XS PT Test by Terrific Care, citing 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 websi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0787-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-12-20 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Terrific Care |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | All Lot Numbers sold by Terrific Care LLC dba Medex Supply |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0787-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.