Device recall
Z-0238-2016: Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M…
FDA device recall · Class II · Focus Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0238-2016 |
|---|---|
| Recall event | 72395 |
| Product | Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic. |
| Product code | OTT |
| Recalling firm | Focus Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2016 |
| 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