Recall Z-2148-2011 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (
| Date | May 5, 2011 (initiated Feb 11, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because: The DxH 800 may fail to meet the carryover specification for NRBC% when the WBC is greater than 50 X 10 to the 3rd power cells/micro L (50 X 10 to the 9th power cells/L) Beckman Coulter indicated the NRBC% carryover is unlikely to have clinical impact. |
| Root cause | Other |
| Action | Beckman Coulter sent an Urgent Product Correction letter, dated February 11, 2011, via US Postal Service to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were informed the issues would be corrected in a future release(s) for the DxH 800. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If consignees have transferred ownership or locat |
| Quantity | 566 units |
| Distribution | Worldwide Distribution - USA including AL, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Australia ,Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India |
| 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 |