Recall Z-1326-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
| Date | Mar 12, 2025 (initiated Nov 13, 2024) |
| Status | Open, Classified |
| Reason | The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results |
| Root cause | Nonconforming Material/Component |
| Action | An IMPORTANT PRODUCT NOTICE letter dated 11/6/24 was sent to customers. Contact your Beckman Coulter representative if your laboratory has experienced wash wheel dispense arm spin mixer motor errors that are not resolved by initializing. See the System Management Chapter section in the DxI 9000 Access Immunoassay Analyzer Instruction for Use (IFU) for steps to initialize the Analyzer. Your Beckman Coulter service representative will contact you to schedule a part replacement that resolves this issue. Please share this information with your laboratory staff and retain this notification as pa |
| Quantity | 245 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 |