FDAJune 19, 2020device

Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below

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

The hazard

Quality Control results were not properly evaluated for QC failures.

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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Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below — Recall Details · AllClear