DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i
FDA device recall Z-0215-2026 · posted 2025-10-21 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- 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.
- Action taken
- An URGENT MEDICAL DEVICE RECALL notification letter dated 9/12/25 was sent to customers. " When ordering tests for a manually diluted sample through the Test Order Entry page, a unique sample ID is required. " Alternatively, use the Dilute and Rerun feature or an automated dilution to measure diluted samples. Refer to Rerunning a Test with a Diluted Sample in the System Help for more information. " Beckman Coulter suggests sharing this letter with your Medical Director to determine if performing a retrospective review of results is necessary. " Beckman Coulter is investigating the root cause of this issue and will implement a correction with a future software release. " Your Beckman Coulter service representative will contact you to schedule the software upgrade when it is available. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact Customer Support Center: " From our website: http://www.beckmancoulter.com
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- CGR
- Quantity affected
- 160 units
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2025-09-19
- Date posted
- 2025-10-21
- Location
- Chaska, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Access Cortisol; DxC 500i Clinical Analyzer (K242190) | Beckman Coulter, Inc. | 2025-03-05 |