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U.S. Department of Health and Human Services

Class 2 Device Recall KOH 10

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  Class 2 Device Recall KOH 10 see related information
Date Initiated by Firm July 01, 2021
Create Date September 10, 2021
Recall Status1 Terminated 3 on May 02, 2023
Recall Number Z-2450-2021
Recall Event ID 88450
Product Classification Discs, strips and reagents, microorganism differentiation - Product Code JTO
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.
Code Information Lot 21137116, UDI 10634853000633
Recalling Firm/
Manufacturer		 Gibson Bioscience
1040 Manchester St
Lexington KY 40508-2422
For Additional Information Contact Becky Neu
859-254-9500
Manufacturer Reason
for Recall		 A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
FDA Determined
Cause 2		 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 in Commerce 11 kits
Distribution US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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