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FDAMarch 9, 2020device

ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

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

The hazard

An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.

What to do

FDA enforcement status: Terminated

Brands named

abbott gmbh co kgabbottabbott gmbh

UPCs

00380740011185

Recall history

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

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