Device recall
Z-1774-2022: Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007
FDA device recall · Class II · Associates of Cape Cod, Inc.
Key facts
| Recall number (Z-number) | Z-1774-2022 |
|---|---|
| Recall event | 90820 |
| Product | Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007 |
| Product code | NQZ |
| Recalling firm | Associates of Cape Cod, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 12, 2024 |
| 510(k) numbers | K191167 |
| FEI number | 1219145 |
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