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Alinity
Abbott GmbH · Model 07P951A · UDI-DI 00380740142797
JJE
Prescription
10
510(k) clearances
78,872
Adverse events (25 deaths)
561
Recalls
173
Facilities
Description
Alinity i Total T4 Assay File
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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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.