Abbott Alinity i Estradiol Reagent Kit — Class II medical device recall Z-1354-2019
Terminated recall by Abbott Ireland Diagnostics Division, reported 2019-05-22, distributed nationwide. Patient results may be falsely elevated. This patient impact only applies to patients currently being treated
| Recall number | Z-1354-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Ireland Diagnostics Division, Co. Longford, Ireland |
| Recall initiated | 2019-02-05 |
| Classified | 2019-05-16 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2020-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CR, CW, CY, CZ, DE, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KR, KW, LB, LT, LU, LV, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, VN, ZA |
| Quantity | 64,618 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1354-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.