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FDAFebruary 21, 2024device

ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

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

The hazard

The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.

What to do

FDA enforcement status: Ongoing

Brands named

abbott laboratoriesabbott

UPCs

0038074000330200380740003296

Recall history

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

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