Home › Device types › JJE
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
FDA product code JJE · Class 1 · Clinical Chemistry
952
Registered devices
78,872
Adverse events
561
Recalls
208
510(k) clearances
Devices with this code
System liquid concentrate — EUROIMMUN Medizinische Labordiagnostika AGAlinity — Abbott GmbHARCHITECT — ABBOTT LABORATORIESNOVEOS House Dust Mite, Dermatophagoides farinae — HYCOR BIOMEDICAL LLCARCHITECT — ABBOTT LABORATORIESChemiluminescence Immunoassay Analyzer — Shenzhen YHLO Biotech Co., Ltd.Alinity — Abbott GmbHAlinity — Abbott GmbHUrine Standard — Diamond Diagnostics Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Alinity — Abbott GmbHCLC480 Chemistry Analyzer W/ISE — CAROLINA LIQUID CHEMISTRIES CORPORATIONAlinity — Abbott GmbHAtellica CH CHK — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Sprinter XL (model 160 samples, IFA/ELISA) — EUROIMMUN Medizinische Labordiagnostika AGAlinity — Abbott GmbHP780 Clinical Chemistry Analyzer with ISE module — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagABX PENTRA 400 ISE — HORIBA ABX SASEUROIMMUN Analyzer I — EUROIMMUN Medizinische Labordiagnostika AGRX daytona plus — RANDOX LABORATORIES LIMITEDVIDAS 3 — BIOMERIEUX SAAlinity — Abbott GmbH
Recent 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 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 |
| 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 |
| 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 |
| 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-mot |
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