Recall Z-1388-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
| Date | Mar 17, 2025 (initiated Feb 5, 2025) |
| Status | Open, Classified |
| Reason | the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results. |
| Root cause | Process design |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 1/30/25 was sent to customers. Affected DxI 9000 Access Immunoassay Analyzers could experience an increase in the following errors: IncubateWheel.Axis MachineControlStatus(Encoder reports that axis position is out of tolerance) WashWheel.Axis MachineControlStatus(Encoder reports that axis position is out of tolerance) This can cause the analyzer to enter the red, or Stopped, system status and any in-process tests are cancelled. There could be a delay in reporting patient test results to the physician. If the error occurs: 1. Con |
| Quantity | 206 units |
| Distribution | US Nationwide. Global 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 |