Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 recallZ-2450-2021 · Gibson Bioscience · initiated Jul 1, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Gibson Bioscience or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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.
Recall details
- Recall number
- Z-2450-2021
- Status
- Terminated
- Initiated by the company
- Jul 1, 2021
- Recalling firm
- Gibson Bioscience
- Quantity
- 11 kits
- Product code
- JTO
- Distribution
- US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
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.
Code information (models, lots, serial numbers)
Lot 21137116, UDI 10634853000633
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Chemmette Reagents 300145Microbiologics Inc. · Discs, strips and reagents, microorganism differentiation1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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