Gibson Bioscience Recall 88450
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.
Gibson Bioscience Recall 88450 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2450-2021 |
| Event ID | 88450 |
| Event 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 Type | Devices |
| Distribution | US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC. |
| Quantity | 11 kits |
| Recall Reason | A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%. |
| Device Classification | 20210922 |
| Device Code Info | Lot 21137116, UDI 10634853000633 |
| Center Classification Date | 20210910 |
| Recall Initiation Date | 20210701 |
| Recalling Firm | Gibson Bioscience |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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