Recall Z-2450-2021 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
Gibson Bioscience
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.
| Date | Jul 1, 2021 |
| Status | Terminated |
| Reason | A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%. |
| 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 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. |
| Quantity | 11 kits |
| Distribution | US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.