DxI 9000 Access Immunoassay Analyzer, Part Number C11137
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | September 19, 2025 |
| Reported | October 29, 2025 |
| Recalling firm | Beckman Coulter, Inc. |
| Country / region | United States MN |
Hazard
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
Affected products
- DxI 9000 Access Immunoassay Analyzer, Part Number C11137
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