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.
Reported: September 22, 2021 Initiated: July 1, 2021 #Z-2450-2021
Product Description
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%.
Details
- Recalling Firm
- Gibson Bioscience
- Units Affected
- 11 kits
- Distribution
- US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
- Location
- Lexington, KY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Gibson Bioscience. Units affected: 11 kits.
Why was this product recalled? ▼
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 22, 2021. Severity: Moderate. Recall number: Z-2450-2021.
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