Recall Z-3125-2011 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
Unicel DxH 800 Coulter Cellular Analysis System Product Usage: UniCel DxH 800 Coulter Cellular Analysis System Instructions for Use PN 629743AD 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 Pa
| Date | Sep 1, 2011 (initiated May 9, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that the probe wash collar tubing may become stretched or trapped at the Sample Aspiration Module (SAM) during routine use of single-tube presentation station. When the tension on the tubing is severe, the tubing may not be able to return to its home state and may pull the wash collar out of alignment with the aspirate probe. The misal |
| Root cause | Pending |
| Action | Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated May 11, 2011 with an attached Product Correction Response Form to all affected customers. The letter provides the customers with an explanation of the problem identified, potential impact should the problem occur and actions to be taken. The letter states that this issue will be corrected in a future hardware release. Customers were instructed to share this information with laboratory staff and retain this notification as part of Quality System documentation. If ownership or location of the analyzer(s) has been transferred to |
| Quantity | 680 units |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines |
| 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 |