FDAJanuary 24, 2020device
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
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 G3+ cartridge; List Number: 03P78-26;2026-04-01
- FDAi-STAT EG7+ cartridge; List Number: 03P76-25;2026-04-01
- FDAi-STAT EG6+ cartridge; List Number: 03P77-25;2026-04-01
- FDAHeraeus, PALAMIX duo. Material Number: 66057897.2026-03-25
- 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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