Device recall
Z-1298-2022: Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software…
FDA device recall · Class II · Haemonetics Corporation
Key facts
| Recall number (Z-number) | Z-1298-2022 |
|---|---|
| Recall event | 90358 |
| Product | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are… |
| Product code | JPA |
| Recalling firm | Haemonetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 27, 2024 |
| 510(k) numbers | K002177, K041502 |
| 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