Device recall
Z-0545-2022: CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the…
FDA device recall · Class II · Immuno-Mycologics, Inc
Key facts
| Recall number (Z-number) | Z-0545-2022 |
|---|---|
| Recall event | 89370 |
| Product | CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919 |
| Product code | GMD |
| Recalling firm | Immuno-Mycologics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2024 |
| 510(k) numbers | K112422 |
| 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