FDANovember 13, 2025device

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

What to do

FDA enforcement status: Ongoing

Brands named

abbott laboratoriesabbott

UPCs

0038074013741006952999490048

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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