ClearanceBrief
Recall Z-0434-2016 ยท GKZ Counter, Differential Cell

Beckman Coulter Inc.

UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

DateDec 16, 2015 (initiated Dec 1, 2015)
StatusTerminated
ReasonBeckman 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.
Root causeSoftware design
ActionBeckman Coulter sent an Urgent Medical Device Recall letter dated December 1, 2015, to all affected customers to inform them that Beckman Coulter is recalling the the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because of the possibility of sample misidentificaton. Customers were informed that during internal testing, Beckman Coulter determined that the software for the DxH systems noted above allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders a
Quantity666 units total (327 units in US)
DistributionWorldwide 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, Jo
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K081930UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Beckman Coulter, Inc., Dec 19, 2008
K120771UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
Beckman Coulter, Inc., Mar 22, 2013
K140911UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
Beckman Coulter, Inc., Sep 5, 2014