FDAMarch 7, 2019device
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) pr...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential performance issues in the Alinity-ci software version 2.5.1
What to do
FDA enforcement status: Terminated
Brands named
abbott gmbh co kgabbottabbott gmbh
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAi-STAT EG6+ cartridge; List Number: 03P77-25;2026-04-01
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- FDAHeraeus, PALAMIX uno. Material Number: 66057893.2026-03-25
- FDAEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;2026-02-11
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