Recall Z-1913-2025 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
| Date | Jun 5, 2025 (initiated Apr 23, 2025) |
| Status | Open, Classified |
| Reason | A new software update (v1.20) 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 | Software design |
| Action | An "URGENT MEDICAL DEVICE RECALL (UMDR)" notification letter dated 4/16/2025 was sent to customers. ACTION: If your laboratory has experienced the red system event and it is not resolved by initializing the analyzer, contact your Beckman Coulter representative and schedule a service visit. 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 retain this notification as part of your laboratory Quality System documenta |
| Quantity | 231 units |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public o |
| 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 |