FDA Device recall Z-1354-2019
Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) us…
- FDA Device
- Class II
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II recall of Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) us… by Abbott Ireland Diagnostics Division, citing patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1354-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-05 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Ireland Diagnostics Division |
| Distribution | US |
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.
Reason
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Identifiers
| code_info | List Number 07P5020 - ALL LOTS and List Number 07P5030 - ALL LOTS. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1354-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.