Recall Z-2074-2011 ยท CEM Electrode, Ion Specific, Potassium
Beckman Coulter Inc.
UniCel DxC 680i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI
| 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 | 4879 units total (3490 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
| K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS Beckman Coulter, Inc., Nov 12, 2004 |