FDAOctober 19, 2023device

Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.

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

The hazard

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

What to do

FDA enforcement status: Ongoing

Brands named

abbott laboratoriesabbott

UPCs

0038074001717000380740016616

Recall history

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

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