Recall Z-1529-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
| Date | Apr 4, 2025 (initiated Jul 12, 2024) |
| Status | Open, Classified |
| Reason | Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users. |
| Root cause | Device Design |
| Action | The firm sent notice of "Urgent Medical Device Recall" to affected consignees (all OUS), dated July 3, 2024. Customers were informed of the potential for barcode read failure error, delay of reporting patient test results, and possibility for a small amount of smoke to be emitted. Consignees were advised that no action was necessary if their laboratory has not observed any RSM Barcode Read Failure error messages. If you do observe any such error messages, or notice smoking or burning smell coming from the Dxl 9000 analyzer, please contact your Beckman Coulter service representative. Beckman |
| Quantity | 30 OUS |
| Distribution | OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and United Kingdom of Great Britain and Northern Ireland. |
| 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 |