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Thermo Scientific™ Sensititre™ ARIS HiQ™ System

TREK DIAGNOSTIC SYSTEMS LIMITED · Model V4000 · UDI-DI 05032384545872

LRG Prescription

510(k) clearances

137

Adverse events (6 deaths)

Recalls

Facilities

Description

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.

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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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.