Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1353-2019 — 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.

U.S. FDA — Device Enforcement · Ireland · 2019-02-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1353-2019
Date of alert: 2019-02-05
Country / jurisdiction: Ireland
Risk level: Class II
Risk type: recall
Brand: Abbott Ireland Diagnostics Division
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1353-2019 — 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.

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