Gibson Bioscience: Medical Device Recall in 2021 - (Recall #: Z-2450-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 1, 2021

Date Posted: September 22, 2021

Recall Number: Z-2450-2021

Event ID: 88450

Reason for Recall:

A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.

Status: Terminated

Product Quantity: 11 kits

Code Information:

Lot 21137116, UDI 10634853000633

Distribution Pattern:

US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.

Voluntary or Mandated:

Voluntary: Firm initiated