Z-2450-2021Class II

Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in...

Name: Z-2450-2021 Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in...
Creator: Gibson Bioscience
Published: 2021-07-01
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2021-07-01 / Terminated

FDA source

Gibson Bioscience began a recall of 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... on 2021-07-01. FDA classified it as Class II and gives the reason as "A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2450-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-01
Posted: 2021-09-10
Terminated: 2023-05-02
Recalling firm: Microbiologics, Inc.
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.
Product code: JTO Discs, Strips And Reagents, Microorganism Differentiation
Reason for recall: A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
FDA 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 [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.
Quantity in commerce: 11 kits
Distribution: US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
Product codes and lots: Lot 21137116, UDI 10634853000633

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2450-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2450-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-10

Product code JTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)