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Alinity
Abbott GmbH · Model 07P941C · UDI-DI 00380740179960
JJE
Prescription
10
510(k) clearances
79,280
Adverse events (25 deaths)
564
Recalls
175
Facilities
Description
Alinity i Total T3 Assay File
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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Get your free API keyRead the docsData 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.