FDA-Device2021-09-22Class II
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.
Gibson Bioscience
Hazard
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
Sold states
US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
Affected count
11 kits
Manufactured in
1040 Manchester St, N/A, Lexington, KY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2450-2021Don't want to check this manually?
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