FDAFebruary 5, 2019device
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.
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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- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.2026-04-03
- FDADepuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.2026-04-03
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