Drug recall
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part…
FDA recall event 81857 · Class I · TERRIFIC CARE LLC
Key facts
| Event ID | 81857 |
|---|---|
| Recall numbers | Z-0787-2019 |
| Recalling firm | TERRIFIC CARE LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 20, 2018 |
| Report date | Feb 13, 2019 |
| Termination date | Dec 29, 2020 |
| City | Passaic |
| State | NJ |
| Country | United States |
| FEI number | 3014100519 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: