Device recall
Z-2040-2016: Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal…
FDA device recall · Class II · Immuno-Mycologics, Inc
Key facts
| Recall number (Z-number) | Z-2040-2016 |
|---|---|
| Recall event | 74113 |
| Product | Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis… |
| Product code | GMJ |
| Recalling firm | Immuno-Mycologics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2017 |
| 510(k) numbers | K791393 |
| 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