FDA Device recall Z-0958-2023
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems
- FDA Device
- Class III
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class III recall of Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems by Abbott Laboratories, citing reaction vessels may contain a potential contaminant that could affect their optical performance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0958-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-11-24 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories |
| Distribution | IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV |
Product
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Reason
Reaction vessels may contain a potential contaminant that could affect their optical performance.
Identifiers
| code_info | UDI-DI/Lots: 00380740129026/000586790 and 000586879 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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All Abbott Laboratories recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0958-2023%22
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