Device recall
Z-1342-2021: LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent…
FDA device recall · Class II · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-1342-2021 |
|---|---|
| Recall event | 87501 |
| Product | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and… |
| Product code | CEW |
| Recalling firm | Diasorin Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2023 |
| 510(k) numbers | K150879 |
| FEI number | 2182595 |
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