Recall Z-0612-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitativ
| Date | Dec 22, 2012 (initiated Nov 1, 2012) |
| Status | Terminated |
| Reason | It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel. |
| Root cause | Device Design |
| Action | Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 1, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return an enclosed Response Form. Contact Technical Support for questions regarding this notice. |
| Quantity | 6,858 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |