UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 an

FDA device recall Z-0433-2016 · posted 2015-12-16 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

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.

Action taken

Beckman 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 at the System Manager. The issue does not occur for edits of released results or for test orders requested through host transmission. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions were instructed to contact Customer Support Center at www.beckmancoulter.com/customersupport/support or via phone (800) 526-7694 in US and Canada. Customers outside of US and Canada are instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-961-5321.

Root cause

Software design

Status

Terminated

Product code

GKZ

Quantity affected

834 units total (594 units in US)

Distribution

Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Colombia, Croatia, Czech Republic, Ecuad

Date initiated

2015-12-01

Date posted

2015-12-16

Date terminated

2017-01-20

Location

Brea, CA

Related 510(k) clearances