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FDAApril 24, 2023device

Alinity i Anti-TPO Reagent Kit, List Number 09P3521

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

The hazard

Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

What to do

FDA enforcement status: Ongoing

Brands named

abbott irelandabbott

UPCs

00380740153892

Recall history

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

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