DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Reported: October 29, 2025 Initiated: September 19, 2025 #Z-0216-2026
Product Description
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Reason for Recall
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.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 571 units
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
DxI 9000 Access Immunoassay Analyzer, Part Number C11137. Recalled by Beckman Coulter, Inc.. Units affected: 571 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2025. Severity: Moderate. Recall number: Z-0216-2026.
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