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.
FDA Recall Z-2450-2021 · Posted None
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Recalling FirmGibson Bioscience
Recall StatusTerminated
Product CodeJTO
Date Initiated2021-07-01
Date Terminated2023-05-02
Product Quantity11 kits
Reason for Recall
A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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