FDA recall Z-2450-2021

Gibson Bioscience · Class II · device

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

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

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