Device recall
Z-1617-2020: TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0…
FDA device recall · Class II · Haemonetics Corporation
Key facts
| Recall number (Z-number) | Z-1617-2020 |
|---|---|
| Recall event | 85120 |
| Product | TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies |
| Product code | JPA |
| Recalling firm | Haemonetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2021 |
| 510(k) numbers | K002177 |
| FEI number | 1219343 |
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