Device Recall UniCel DxH 600 COULTER Cellular Analysis System 의 리콜

Recall

72773

Class 2

Z-0434-2016

2015-12-01

2015-12-16

Terminated

United States

2017-01-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142196

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.

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.