Recall Z-1972-2011 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A64871, UniCel DxC 680i Part #: A64903, UniCel DxC 800 Part #: A11816, UniCel DxC 800 PRO Part #: A11812, UniCel DxC 860i Part #: A64935, and UniCel DxC 880i Part #: A59102.
| Date | Apr 13, 2011 (initiated Nov 16, 2010) |
| Status | Terminated |
| Reason | The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly. |
| Root cause | Pending |
| Action | The recall communication was initiated with Beckman Coulter forwarding a Product Corrective Action Letter (PCA) dated November 16, 2010 to the affected customers. The recall notice explained the reason for recall and asked that customers take the following actions: (1) Customers with a service contract will have hose clamp covers installed by their Field Service Engineer during the next scheduled Preventive Maintenance (PM). A kit can be ordered through their Customer Service Representative if consignees prefer not to wait for the next Preventive Maintenance visit and (2) Customers without a s |
| Quantity | 1,535 units |
| Distribution | Worldwide Distribution--United States and countries of Angola, Australia, Belgium, Bulgaria, China, Columbia, Czech Republic, Denmark, Eritrea, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Reunion, Serbia, |
| FDA record | Open on fda.gov |