Drug recall
Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent…
FDA recall event 82129 · Class II · Abbott Ireland Diagnostics Division
Key facts
| Event ID | 82129 |
|---|---|
| Recall numbers | Z-1353-2019, Z-1354-2019 |
| Recalling firm | Abbott Ireland Diagnostics Division |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone. |
| Initiation date | Feb 5, 2019 |
| Report date | May 22, 2019 |
| Termination date | Aug 21, 2020 |
| City | Co. Longford |
| Country | Ireland |
| FEI number | 3005094123 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: