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.
Z-2450-2021
Product summary
- Event
- Event 88450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 kits
- Official record key
device-enforcement:Z-2450-2021
Official wording
Reason: A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
Code information: Lot 21137116, UDI 10634853000633
Distribution pattern: US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
Derived failure modes
-
Unknown
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.