Device recall
Z-1686-2017: Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and…
FDA device recall · Class II · Focus Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1686-2017 |
|---|---|
| Recall event | 76619 |
| Product | Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila. |
| Product code | LHL |
| Recalling firm | Focus Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2017 |
| FEI number | 2023365 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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