Z-2450-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- July 1, 2021
- Termination Date
- May 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 kits
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%.
Distribution Pattern
US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
Code Information
Lot 21137116, UDI 10634853000633