Recall Z-2272-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. Catalog No. UniCel DxC 800 Synchron Clinical Systems UniCel DxC 600 Synchron Clinical Systems UniCel DxC 600i
| Date | Jul 22, 2016 (initiated Apr 22, 2014) |
| Status | Terminated |
| Reason | Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems. |
| Root cause | Nonconforming Material/Component |
| Action | An Important Product Notice dated 4/22/14 was sent to all their customers to inform them that Beckman Coulter has identified a manufacturing issue with a plastic fitting on the No Foam Bottle Assembly which may crack and cause No Foam solution to leak. The letter informs the customers of the impact, action to be taken, and resolution. Customers are asked to inspect the No Foam Bottle Assembly for leaks prior to refilling the bottle. If leaks occur, customers should contact Customer Support Center following the instructions provided. Customers are instructed to complete the enclosed res |
| Quantity | 3,540 units total (1,067 units in US) |
| Distribution | Worldwide Distribution -- United Arab Emirates, Angola, Australia, Belgium, Bulgaria, Canada, Switzerland, China, Colombia, Costa Rica , Czech Republic, Germany, Denmark, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, J |
| 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 |
| K060256 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM Beckman Coulter, Inc., Feb 27, 2006 |
| K103842 | UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 Beckman Coulter, Inc., Apr 27, 2011 |