# FDA recall Z-2450-2021

> **Gibson Bioscience** · Class II · device recall initiated 2021-07-01.

## 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 for recall

A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.

## Distribution

US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.

## Key facts

- **Recall number:** Z-2450-2021
- **Recalling firm:** Gibson Bioscience
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-01
- **Report date:** 2021-09-22
- **Termination date:** 2023-05-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, KY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2450-2021

## Citation

> AI Analytics. FDA recall Z-2450-2021. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2450-2021. Source: US FDA. Licensed CC0.

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