Beckman Coulter Inc. recalls UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel D…

Recall date

December 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0432-2016

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, J…

Why it was recalled

Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, 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 benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.