Device recall
Z-2301-2020: Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple…
FDA device recall · Class II · Immuno-Mycologics, Inc
Key facts
| Recall number (Z-number) | Z-2301-2020 |
|---|---|
| Recall event | 85368 |
| Product | Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen |
| Product code | GMJ |
| Recalling firm | Immuno-Mycologics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 27, 2022 |
| 510(k) numbers | K830837 |
| FEI number | 1627497 |
At a glance
- 1–9 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