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FDANovember 21, 2018device

Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

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

The hazard

Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

What to do

FDA enforcement status: Terminated

Brands named

abbott ireland diagnostics divisionabbottabbott ireland

UPCs

00380740160616

Recall history

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

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