FDA Device recall Z-0107-2024
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below by Beckman Coulter, citing the firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0107-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-12 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Reason
The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.
Identifiers
| code_info | UDI/DI 15099590732103, All DxI 9000 Access Immunoassay Analyzer running software version 1.15 or prior |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0107-2024%22
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