FDA Medical Device Recalls (openFDA)
Gibson Bioscience: 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 number
- Z-2450-2021
- Recalling firm
- Gibson Bioscience
- 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.
- Status
- Terminated
- Initiated
- 2021-07-01
- Posted
- not on file
- Terminated
- 2023-05-02
- Reason
- A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
- Root cause
- Mixed-up of materials/components
- Action
- 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 recall@microbiologics.com, 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 recall@microbiologics.com with questions or concerns. Collect calls may be made.
- Quantity
- 11 kits
- Distribution
- US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
- Lot, serial or model codes
- Lot 21137116, UDI 10634853000633
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTO
- Firm FEI
- 1050138
- Firm city
- Lexington
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28