Device recall
Z-2450-2021: Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH…
FDA device recall · Class II · Gibson Bioscience
Key facts
| Recall number (Z-number) | Z-2450-2021 |
|---|---|
| Recall event | 88450 |
| Product | Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for… |
| Product code | JTO |
| Recalling firm | Gibson Bioscience |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2023 |
| FEI number | 1050138 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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