FDA Device recall Z-0739-2023
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 by Abbott Molecular, citing reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0739-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-22 |
| Published | 2022-12-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Molecular |
| Distribution | n/a |
Product
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Reason
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Identifiers
| code_info | Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499 |
|---|
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-0739-2023%22
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