FDA Device recall Z-2735-2024
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137
- FDA Device
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of DxI 9000 Access Immunoassay Analyzer, Catalog #C11137 by Beckman Coulter, citing when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer do….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2735-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-22 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Reason
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.
Identifiers
| code_info | Software versions 1.17.0 or below, UDI-DI 15099590732103. |
|---|
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-2735-2024%22
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