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ETEST® Flucytosine (FC)
BIOMERIEUX SA · Model ETEST® Flucytosine (FC) · UDI-DI 03573026548896
NGZ
Prescription
1
510(k) clearances
53
Adverse events (1 deaths)
4
Recalls
8
Facilities
Description
Etest is a quantitative technique for determining susceptibility of antifungal. It provides a gradient of 15 doubling dilutions for MIC determination.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-24 | Remel, Inc | Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory i |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2017-04-20 | Biomerieux Inc | The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). |
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