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Fungal Serology
MICROBIOLOGICS INC. · Model 200120 · UDI-DI 10634853000091
10
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities
Description
Histoplasma capsulatum Antigen (H&M), 1mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-04 | Immuno-Mycologics, Inc | False positive results due to potential contamination of reagent. |
| 2016-05-09 | Immuno-Mycologics, Inc | The device was found to have bacterial contamination. |
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