FDAFebruary 5, 2019device

Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.

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

The hazard

Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.

What to do

FDA enforcement status: Terminated

Brands named

abbott ireland diagnostics divisionabbottabbott ireland

Recall history

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

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