Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, auto
FDA device recall Z-0021-2013 · posted 2012-10-09 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results.
- Action taken
- Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated April 3, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return an enclosed Response Form. Customers were notified that Beckman Coulter is in the process of developing and testing a design change that will prevent the mix chamber waste port from plugging. Customers with questions were instructed to contact Beckman Coulter Customer service at (800) 526-7694 in the US and Canada or contact their local Beckman Coulter representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 1281 units total (693 units in the US)
- Distribution
- Worldwide Distribution-USA (nationwide) and the counties of Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kor
- Date initiated
- 2012-04-03
- Date posted
- 2012-10-09
- Date terminated
- 2013-06-20
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K081930) | Beckman Coulter, Inc. | 2008-12-19 |