FDAJuly 26, 2022device

ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

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

The hazard

One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

What to do

FDA enforcement status: Ongoing

Brands named

abbott laboratoriesabbott

UPCs

00380740048525

Recall history

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

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