Device recall
Z-2976-2020: Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage…
FDA device recall · Class III · Oxford Immunotec
Key facts
| Recall number (Z-number) | Z-2976-2020 |
|---|---|
| Recall event | 86003 |
| Product | Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma… |
| Product code | OJN |
| Recalling firm | Oxford Immunotec |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 13, 2021 |
| FEI number | 3006017427 |
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