Recall Z-2450-2021— Gibson Bioscience

Name: FDA recall Z-2450-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-01

Class II · Terminated

Class II FDA medical device recall by Gibson Bioscience, initiated 2021-07-01, terminated 2023-05-02. FDA's recall record names no specific 510(k) clearance for this event. 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%..

Recalling firm: Gibson Bioscience
Classification: Class II
Status: Terminated
Initiated: 2021-07-01
Terminated: 2023-05-02
Firm location: Lexington, KY, United States

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%.

Data sourced from openFDA. This site is unofficial and independent of the FDA.