Recall Z-1387-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
| Date | Mar 17, 2025 (initiated Feb 6, 2025) |
| Status | Open, Classified |
| Reason | Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results. |
| Root cause | Device Design |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter was sent to customers beginning on 2/6/25. Beckman Coulter has determined that a DxI 9000 Access Immunoassay Analyzer containing tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. If the analyzer experiences the issue described above, it can lead to the analyzer entering the red, or Stopped, system status due to Reagent Storage and Tip Stocker "axis is out of tolerance" errors. Any in process tests that require addition of reagent at the tim |
| Quantity | 80 units |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, TX, WA. |
| 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 |