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Sensititire® OptiRead™
REMEL, INC. · Model V3030 · UDI-DI 00848838074530
2
510(k) clearances
137
Adverse events (6 deaths)
13
Recalls
10
Facilities
Description
The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates for non-fastidious and fastidious Gram positive cocci and non fastidious Gram negative organisms, through the use of dedicated Sensititre® SWIN software. MIC and BP Susceptibility plates can either be read manually or automatically on the Sensititre OptiRead™, Autoreader® or the ARIS® in combination with theAutoreader® or OptiRead™.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-12 | Remel, Inc | Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. |
| 2020-12-02 | Beckman Coulter Inc. | Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus dapto |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 |
| 2019-10-21 | Beckman Coulter Inc. | WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 |
| 2019-09-04 | Beckman Coulter Inc. | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control |
| 2019-09-04 | Beckman Coulter Inc. | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control |
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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.