Recall Z-2070-2011 ยท JGS Electrode, Ion Specific, Sodium
Beckman Coulter Inc.
Synchron LX I 725 The Synchron LXi 725 System combines the Synchron LX20 PRO analyzer and the Access 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquotter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or LX20 PRO analyzer according to programming requi
| Date | Apr 26, 2011 (initiated Oct 22, 2010) |
| Status | Terminated |
| Reason | This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified. |
| Root cause | Environmental control |
| Action | The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel DxC Clinical Systems Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete a |
| Quantity | 1,410 units (503 in US) |
| Distribution | Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Ku |
| 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 |