Device recall
Z-0360-2019: CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips…
FDA device recall · Class I · Roche Diagnostics Corporation
Key facts
| Recall number (Z-number) | Z-0360-2019 |
|---|---|
| Recall event | 81093 |
| Product | CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160; |
| Product code | GJS |
| Recalling firm | Roche Diagnostics Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 16, 2020 |
| 510(k) numbers | K071041, K093460, K170960, K180684 |
| FEI number | 1823260 |
At a glance
- 1–9 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