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FDAMay 21, 2019device

The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a scalable design to provid...

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

The hazard

All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).

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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