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BIOLIS 24i Premium

TOKYO BOEKI MEDISYS INC. · Model 23-01-0000 · UDI-DI 04580262020016

JJE

510(k) clearances

79,280

Adverse events (25 deaths)

561

Recalls

175

Facilities

Description

Biolis 24i Premium is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. Biolis 24i Premium with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, Biolis 24i Premium with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.

Recalls

Date	Firm	Reason
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
2025-10-01	Beckman Coulter, Inc.	An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to ente
2025-10-01	Beckman Coulter, Inc.	An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to ente
2025-06-25	Beckman Coulter, Inc.	Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings

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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.