Thermo Scientific™ Sensititre™ ARIS HiQ™ System V4000Recalls & reported problems
Trek Diagnostic Systems Limited · The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobial susceptibility testing and identification of bacterial pathogens; designed to accommodate up to 100 Sensititre™ microtitre plates within a single instrument. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Feb 12, 2025Class IIOpen, Classified
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Z-1395-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems devices
- MicroScan B1018-284Beckman Coulter, Inc. · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems2 recalls2 reports
- MicroScan B1018-440Beckman Coulter, Inc. · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems1 recall1 death2 reports
- MicroScan B1018-496Beckman Coulter, Inc. · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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