Recall Z-0216-2026 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
| 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 | 571 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer Beckman Coulter, Inc., Nov 10, 2022 |