Recall Z-0215-2026 ยท CGR Radioimmunoassay, Cortisol
Beckman Coulter, Inc.
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
| Date | Oct 21, 2025 (initiated Sep 19, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 160 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer Beckman Coulter, Inc., Mar 5, 2025 |