FDA Device recall Z-1602-2024
Alinity m System, Part Number: 08N53-002
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of Alinity m System, Part Number: 08N53-002 by Abbott Molecular, citing the Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1602-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-20 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Molecular |
| Distribution | US |
Product
Alinity m System, Part Number: 08N53-002
Reason
The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
Identifiers
| code_info | Part Number: 08N53-002; UD/DI: 00884999048034. Not Serial Number specific |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1602-2024%22
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