Home › REMEL, INC. › SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
REMEL, INC. · Model YO10 · UDI-DI 00848838036835
10
510(k) clearances
53
Adverse events (1 deaths)
4
Recalls
8
Facilities
Description
The Sensititre® YeastOne® Susceptibility system is a micro-version of the broth dilution susceptibility test. Various antifungal agents are serially diluted to concentrations bridging the range of the clinical interest in autoclaved diluent, which contains a colorimetric growth indicating compound. Each micro-dilution plate is individually packaged in foil. After inoculation, plates are sealed with an adhesive seal, incubated at 35°C for 24 hours and examined for growth.
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). |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.