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ANTI-BACTERIAL DETERGENT (Detergent)

RANDOX LABORATORIES LIMITED · Model RX8106 · UDI-DI 05055273210378

JJE Prescription
10
510(k) clearances
79,280
Adverse events (25 deaths)
564
Recalls
175
Facilities

Description

Antibacterial Detergent is used for cleaning the instrument probe and reaction cuvettes.

Recalls

DateFirmReason
2026-09-02Beckman 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
2026-09-02Beckman 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
2026-08-03Beckman 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
2026-07-15Beckman 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
2026-07-15Beckman 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
2026-01-20Roche 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
2025-11-26Beckman 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
2025-11-26Beckman 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
2025-11-13Abbott LaboratoriesAbbott 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
2025-11-07Beckman 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.