Device recall
Z-0348-2023: GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent…
FDA device recall · Class II · Greer Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0348-2023 |
|---|---|
| Recall event | 91078 |
| Product | GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies. |
| Product code | DGW |
| Recalling firm | Greer Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2026 |
| FEI number | 1011574 |
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