FDA Device recall Z-2544-2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137 by Beckman Coulter, citing the reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2544-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-22 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Reason
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.
Identifiers
| code_info | Software versions 1.17 and 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-2544-2024%22
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