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QUANTA-Lyser® 3000 ELISA/IFA

INOVA DIAGNOSTICS, INC. · Model VS3000 · UDI-DI 08426950865094

JJE

510(k) clearances

79,980

Adverse events (25 deaths)

564

Recalls

176

Facilities

Description

QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a variety of analytes. QUANTA-Lyser is intended to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in preparation for microscope analysis and photometric measurement of microwell plates.

Recalls

Date	Firm	Reason
2026-09-02	Beckman Coulter Inc.	Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to us
2026-09-02	Beckman Coulter Inc.	Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use
2026-08-03	Beckman Coulter Mishima K.K.	Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching th
2026-07-15	Beckman Coulter Inc.	a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of
2026-07-15	Beckman Coulter Inc.	a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of
2026-01-20	Roche Diagnostics Operations, Inc.	Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended
2025-11-26	Beckman Coulter, Inc.	Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multi
2025-11-26	Beckman Coulter, Inc.	Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multi
2025-11-13	Abbott Laboratories	Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance i
2025-11-07	Beckman Coulter, Inc.	It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusi

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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.