Device recall
Z-0673-2025: Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0673-2025 |
|---|---|
| Recall event | 95738 |
| Product | Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma. |
| Product code | CEW |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K232791 |
| FEI number | 2050012 |
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