Recall Z-1926-2025 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
| Date | Jun 6, 2025 (initiated Apr 23, 2025) |
| Status | Open, Classified |
| Reason | A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay. |
| Root cause | Nonconforming Material/Component |
| Action | An "URGENT MEDICAL DEVICE RECALL (UMDR)" notification letter dated 4/16/25 was sent to customers. ACTION: If your laboratory encounters the system event described in this letter: Perform a system initialization to resume normal operation. Repeat testing for any canceled tests. No action is required if your laboratory has not observed the system event listed above. RESOLUTION: Beckman Coulter will release a modification for this issue. Your service representative will schedule the modification installation when it is available. Please share this information with your laboratory staff and |
| Quantity | 324 units |
| Distribution | Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of China, India, United Kingdom of Great Britain and Northern Ireland, Hungary, Austria, Portugal, Croatia |
| 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 |