Recall Z-0147-2014 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a table
| Date | Nov 4, 2013 (initiated Sep 24, 2013) |
| Status | Terminated |
| Reason | Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamb |
| Root cause | Under Investigation by firm |
| Action | The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated September 12, 2013, its customers. The letter includes the products descriptions and codes, issue, impact, action, resolution, instructions to the customers, and contact information. The customers were instructed to review the three samples analyzed prior to error message,if you experience a "Vent/overflow chamber detected overflow' error; to avoid physical contact with a possible leak by continuing to use personal protective equipment as recommended in the Instructions for Use and by national regulations; share this |
| Quantity | 1,025 units |
| Distribution | Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama, Poland, Portugal Qatar, Russian Federation, Spain, Sweden, S |
| FDA record | Open on fda.gov |