FDA Device recall Z-2450-2021
Potassium Hydroxide 10% (KOH 10%), Cat
- FDA Device
- Class II
- terminated
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of Potassium Hydroxide 10% (KOH 10%), Cat by Gibson Bioscience, citing A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2450-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-01 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Gibson Bioscience |
| Distribution | CA, CO, KY, ME, NC, NY, SC |
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 direct microscopic observation.
Reason
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
Identifiers
| code_info | Lot 21137116, UDI 10634853000633 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2450-2021%22
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