Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demon
Summary
The FDA issued a Class II for Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (K by Gibson Bioscience. Reason: A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%..
Details
Source
Device Recall
External ID
Z-2450-2021
Action Date
2021-09-22
Status
Terminated
Category
device
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.
Lot/Code Info: Lot 21137116, UDI 10634853000633
Quantity Affected: 11 kits
Reason for Recall
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
Distribution
US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-01
Company
Lexington, KY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Gibson Bioscience) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Gibson Bioscience have FDA actions?
This is the only FDA action we have on record for Gibson Bioscience in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2450-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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