FDA Device recall Z-1349-2023
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4 by Abbott Molecular, citing the instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returne….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1349-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-11 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Molecular |
| Distribution | PA |
Product
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Reason
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
Identifiers
| code_info | Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139. |
|---|
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-1349-2023%22
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