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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: May 16, 2019
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Affected Products

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.

List Number 7K72-20 - ALL LOTS, List Number 7K72-25 - ALL LOTS, and List number 7K72-35 - ALL LOTS.

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.

List Number 07P5020 - ALL LOTS and List Number 07P5030 - ALL LOTS.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82129
Status: Resolved
Manufacturer: Abbott Ireland Diagnostics Division
Manufactured In: Ireland
Units Affected: 2 products (2,724; 64,618)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.