Lexington, KY, United States
Gibson Bioscience recalls
1 recall recorded since 2018, most recently on 1 July 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 July 2021
- Terminated
- 2 May 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2450-2021
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.