CoaguChek XS PT Test — Class I medical device recall Z-0787-2019
Terminated recall by TERRIFIC CARE LLC, reported 2019-02-13, distributed nationwide. Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchase
| Recall number | Z-0787-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TERRIFIC CARE LLC, Passaic, NJ, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2019-02-01 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2020-12-29 |
| Distributed | Nationwide (US) |
| Quantity | 793 boxes |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0787-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.