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FDAOctober 19, 2023device

Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used...

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

00380740137366

Recall history

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

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Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used... — Recall Details · AllClear