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Sensititre™ Vizion™

TREK DIAGNOSTIC SYSTEMS LIMITED · Model V2021 · UDI-DI 05032384474509

JWY Prescription

510(k) clearances

153

Adverse events

Recalls

Facilities

Description

Sensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre susceptibility plate and sends it to the SWIN software, so that the results are displayed at the SWIN PC and can be read by the user. The Sensititre™ Vizion™ is intended for use with the Sensititre™ MIC or BP Susceptibility Test System. The Sensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre 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, and for non-fastidious Gram-positive, Gram-negative, and fastidious organisms comprising of Haemophilus 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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Data 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.