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FDAAugust 28, 2018device

Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.

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

The hazard

There is a potential to generate falsely elevated serum or plasma chloride results when using the product.

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratoriesabbott

UPCs

00380740019327

Recall history

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

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