Device recall
Z-1329-2019: Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease…
FDA device recall · Class II · Associates of Cape Cod, Inc.
Key facts
| Recall number (Z-number) | Z-1329-2019 |
|---|---|
| Recall event | 82551 |
| Product | Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum… |
| Product code | NQZ |
| Recalling firm | Associates of Cape Cod, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2020 |
| FEI number | 1219145 |
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