Recall Z-1374-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. Part Number: A54376, Synchron LXi 725 APF, Part Number: A54377, Synchron LXi 725 AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
| Date | Apr 6, 2012 (initiated Sep 11, 2008) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay. |
| Root cause | Software design |
| Action | Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their local Beckman Coulter representa |
| Quantity | 2948 units total (2762 units in the US) |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023049 | SYNCHRON LX I 725 CLINICAL SYSTEM Beckman Coulter, Inc., Oct 4, 2002 |