FDA Device recall Z-1696-2023
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
- FDA Device
- Class III
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class III recall of Alinity i Anti-TPO Reagent Kit, List Number 09P3521 by Abbott Ireland, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1696-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-04-24 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Ireland |
| Distribution | US |
Product
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Reason
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).
Identifiers
| code_info | UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1696-2023%22
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