Alinity i Anti-TPO Reagent Kit — Class III medical device recall Z-1696-2023
Ongoing recall by Abbott Ireland Limited, reported 2023-06-14, distributed nationwide. Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume t
| Recall number | Z-1696-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Ireland Limited, Sligo, Ireland |
| Recall initiated | 2023-04-24 |
| Classified | 2023-06-08 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 110 kits |
| UPC / GTIN / UDI-DI | 00380740153892 |
| Lot numbers | 46009FN00 |
| Expiration dates | 2024-07-20 |
Product
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Reason for recall
Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
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-1696-2023. 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.