medical Class II Updated 2019-05-22

Abbott Ireland Diagnostics Division recalls Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: List Number 7K72-20 - ALL LOTS, List Number 7K72-25 - ALL LOTS, and List number 7K72-35 - ALL LOTS.
View official government recall

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