Device recall
Z-0787-2019: CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The…
FDA device recall · Class I · TERRIFIC CARE LLC
Key facts
| Recall number (Z-number) | Z-0787-2019 |
|---|---|
| Recall event | 81857 |
| 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… |
| Product code | GJS |
| Recalling firm | TERRIFIC CARE LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 29, 2020 |
| FEI number | 3014100519 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database