—#112709

Product

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: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K081930
Affected lot / code info: all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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, Korea, Republic of Kuwait, Macao, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Philippines, Puerto Rico, Qatar, Romania, Russian, Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Timeline

Recall initiated: 2012-04-03
Posted by FDA: 2012-10-09
Terminated: 2013-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112709. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.