Device recall
Z-0645-2017: LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II…
FDA device recall · Class II · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-0645-2017 |
|---|---|
| Recall event | 75478 |
| Product | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in… |
| Product code | CHP |
| Recalling firm | Diasorin Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2017 |
| FEI number | 2182595 |
At a glance
- None 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