FDA Device recall Z-0710-2022
Alinity m Integrated Reaction Units (IRU)
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of Alinity m Integrated Reaction Units (IRU) by Abbott Molecular, citing there is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0710-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-11 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Molecular |
| Distribution | US |
Product
Alinity m Integrated Reaction Units (IRU)
Reason
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Identifiers
| code_info | List Number 09N26-010, Lot Numbers/UDI: 1) 766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010 2) 770433 / (0…List Number 09N26-010, Lot Numbers/UDI: 1) 766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010 2) 770433 / (01)20884999047864(10)770433(11)210621(240)09N26-010 3) 771200 / (01)20884999047864(10)771200(11)210712(240)09N26-010 4) 771201 / (01)20884999047864(10)771201(11)210719(240)09N26-010 5) 773642 / (01)20884999047864(10)773642(11)210723(240)09N26-010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0710-2022%22
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