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SENSITITRE VIZION
REMEL, INC. · Model V2021 · UDI-DI 00848838074509
JWY
Prescription
10
510(k) clearances
153
Adverse events
78
Recalls
9
Facilities
Description
The Sensititre Viin ~ isitn- ouewith. the. SensititreO. MWC or HP31 Susceptibility Test System. The "Sensititre® Vizion® is an instrument that takes a digital image of a Senisititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for nonfastidious Gram positive, Grain negative and fastidious organisms comprising of Hczemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-01 | Remel, Inc | Product may have an off color affecting perfomance |
| 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 |
| 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 |
| 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 |
| 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 |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
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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.