Recall Z-1905-2010 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029
| Date | Jun 25, 2010 (initiated Jul 28, 2009) |
| Status | Terminated |
| Reason | The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It was determined that there is a potential for a false increase in platelet results, due to micro-bubbles. This situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted. |
| Root cause | Other |
| Action | Beginning on July 29, 2009 Customers were contacted by Customer Technical Support (CTS) personnel and provided with the Product Corrective Action (PCA) letter. The PCA letter informed customers of the issue, the impact of the issue and actions/resolutions required by Beckman Coulter Service representative ad the affected consignee. The consignees were informed that their Beckman Coulter Service representative has made temporary changes to the Supplies setup. In addition to the Supplies setup change, consignees were instructed that one of the following workflow options must be implemented to e |
| Quantity | 7 |
| Distribution | Nationwide to: AZ, LA, IL, NY, PA & TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081930 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc., Dec 19, 2008 |