FDA Device recall Z-1115-2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137
- FDA Device
- Class II
- completed
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137 by Beckman Coulter, citing A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1115-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-01-03 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Reason
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Identifiers
| code_info | UDI/DI 15099590732103, serial numbers: 300208, 300201, 300184, 300185, 300169, 300225, 300175, 300172, 300221, 300209,…UDI/DI 15099590732103, serial numbers: 300208, 300201, 300184, 300185, 300169, 300225, 300175, 300172, 300221, 300209, 300211, 300212, 300213, 300214, 300215, 300210, 300174, 300226, 300204, 300216, 300217, 300170, 300220, 300176, 300188, 300199, 300200, 300177, 300222, 300224, 300173, 300181, 300202, 300191, 300223, 300171, 300186, 300190, 300203, 300178, 300195, 300189, 300198, 300227, 300228, 300168, 300194, 300205, 300206, 300207, 300197, 300218, 300179, 300182, 300192, 300219, 300193, 300183, 300180, 300187, 300196. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1115-2025%22
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