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.
Recall
- Recall Number
- Z-2450-2021
- Event Number
- 88450
- Firm
- Gibson Bioscience
- FEI Number
- 1050138
- Product Code
- JTO
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- July 1, 2021
- Terminated
- May 2, 2023
- Address
- 1040 Manchester St, Lexington, KY, 40508-2422
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.
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
On July 1, 2021, the firm, Microbiologics, distributed "Urgent Medical Device Recall " letters to affected customers through mail and email. Customers were informed of the product issue. Customers were instructed to discard all affected inventory immediately. In addition, they were to complete and return the customer response form to [email protected], and keep the recall letter for their records. Customers may contact Microbiologics if a replacement is needed. Please contact Microbiologics' Recall Support Team at 320.229.7073 or [email protected] with questions or concerns. Collect calls may be made.
US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
11 kits