FDA Device recall Z-1025-2026
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260 by Beckman Coulter, citing beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after mult….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1025-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-26 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Reason
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Identifiers
| code_info | A71460: UDI 15099590369224 A71461: UDI 15099590369248 A30260: UDI 15099590341602 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-14 · Beckman Coulter - DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3…
FDA Device · Class II · 2026-10-14 · Beckman Coulter - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C…
FDA Device · Class II · 2026-08-26 · Beckman Coulter
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1025-2026%22
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