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Terminated

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 Recall Z-0021-2013 · Posted 2012-10-09

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2012-04-03
Date Terminated2013-06-20
Product Quantity1281 units total (693 units in the US)

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.

Firm Action

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

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081930UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMBeckman Coulter, Inc. · 2008-12-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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