Home › Device types › JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
FDA product code JJE · Class 1 · Clinical Chemistry
983
Registered devices
79,980
Adverse events
564
Recalls
208
510(k) clearances
Devices with this code
Alinity — Abbott GmbHAlinity — Abbott GmbHAtellica IMT Dilution Check — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESTENDIGO — Fujirebio EuropeSprinter XL (model 160 samples, IFA/ELISA) — EUROIMMUN Medizinische Labordiagnostika AGAlinity — Abbott GmbHDxC AU — Beckman Coulter, Inc.ARCHITECT — Abbott Ireland DiagnosticsARCHITECT — ABBOTT LABORATORIESTitin-s ELISA & CLIA Analyzer — MONOBIND, INC.Bio30+ Physiological HR — BIOCHROM LIMITEDARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESAlinity — Abbott GmbHADVIA Centaur® Ancillary Probe Wash 2 — Siemens Healthcare Diagnostics Inc.ACE Alera® — ALFA WASSERMANN, INC.SelectaLyte — AWARENESS TECHNOLOGY, INCORPORATEDPictus 500 Clinical chemistry analyzer — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagAlinity — Abbott GmbHIMMULITE® 2000 Systems Microsampling Tube Caps — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAtellica CH Conditioner — Siemens Healthcare Diagnostics Inc.cobas e 411 Immunoassay Analyzer — Roche Diagnostics GmbHSample supply unit — Roche Diagnostics GmbH
Recent 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 |
| 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 Ch |
| 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 AlarmD |
| 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 u |
| 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 u |
| 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 |
| 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 shutdo |
| 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 shutdo |
| 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 pot |
| 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 h |
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