The Recall Desk

FDA (Devices) recall action 82129

Abbott Ireland Diagnostics Division recalled 2 products on 2019-05-22

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-05-22
Critical
0
Units
67,342

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-05-22

    Abbott Alinity i Estradiol Reagent Kit Recalled for False Results

    Abbott Ireland Diagnostics Division is recalling Alinity i Estradiol Reagent Kits because patient results may be falsely elevated for individuals treated with Mifepristone.

    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.
    Category
    Distribution
    36 states
  • HighFDA (Devices)··2019-05-22

    Abbott ARCHITECT Estradiol Reagent Kit Recall for Mifepristone Interference

    Abbott is recalling ARCHITECT Estradiol Reagent Kits because patient results may be falsely elevated for individuals currently or recently treated with Mifepristone.

    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.
    Category
    Distribution
    36 states