Alinity i Ferritin Reagent Kit — Class II medical device recall Z-2208-2019
Terminated recall by Abbott Ireland Diagnostics Division, reported 2019-08-14, distributed in AR, FL, GA, MD, OK, VA. Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the rea
| Recall number | Z-2208-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Ireland Diagnostics Division, Co. Longford, N/A, Ireland |
| Recall initiated | 2018-11-21 |
| Classified | 2019-08-07 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2021-03-25 |
| Distributed | AR, FL, GA, MD, OK, VA |
| Quantity | 216 units |
| UPC / GTIN / UDI-DI | 00380740131487 |
Product
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
Reason for recall
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
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-2208-2019. 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.