medical Class II Updated 2019-05-22

Abbott Ireland Diagnostics Division recalls Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alin

Recalled Product

Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.


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 07P5020 - ALL LOTS and List Number 07P5030 - ALL LOTS.
View official government recall

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