FDA Device recall Z-0025-2025
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137 by Beckman Coulter, citing when the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0025-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-18 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | FL, GA, IN, KS, NH, NJ, OK, PA, TX |
Product
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reason
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
Identifiers
| code_info | UDI-DI: 15099590230623; U.S. serial numbers: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292,…UDI-DI: 15099590230623; U.S. serial numbers: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292, 300195, 300227, 300228, 300205, 300207, 300206, 300182, 300192, and 300234. OUS serial numbers have been requested. |
|---|
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-0025-2025%22
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