Recall Z-1518-06 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc
UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer
| Date | Sep 23, 2006 (initiated Jul 28, 2006) |
| Status | Terminated |
| Reason | The neck of the wash buffer cube can be extended higher than intended possibly causing the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. This may lead to incorrect assay results. |
| Root cause | Other |
| Action | A Product Corrective Action (PCA) letter was sent on July 28, 2006 to all Dxl customers to inform them that due to a recent change in packaging it is possible that the neck of the wash buffer cube can be extended higher than intended. This condition can cause the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. If they are running System software version 2.2.2 (distributed beginning March 2006) and greater it will detect the premature out-of-buffer state, thus preventing the potential for erroneous |
| Quantity | 12,947 units |
| Distribution | Worldwide distribution --- including USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc., Jan 28, 2003 |