Recall Z-2385-2008 ยท JGS Electrode, Ion Specific, Sodium
Beckman Coulter Inc
SYNCHRON LXi 725 System
| Date | Sep 21, 2008 (initiated Apr 3, 2008) |
| Status | Terminated |
| Reason | The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision. |
| Root cause | Nonconforming Material/Component |
| Action | A Product Corrective Action (PCA) letter with attached Fax-Back Customer Response form was mailed on April 16, 2008 via US Postal mail to all affected customers with Access and Access 2 Immunoassay Systems, Synchron LXi 725 Systems and UniCel DxC 600i Systems. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump Mfg. No. 01-00772205 with a SN higher than 2234980. A toll free Customer Technical Support telephone was included in the letter. After further investigation by the firm, an Updated PCA letter with attached Fax-Back Custom |
| Quantity | 694 Worldwide; 656 in US & 38 in Canada total for all products |
| Distribution | Nationwide, and in 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 |