Device Recall UniCel Closed Tube Aliquotter for UniCel DxC 660i, 680i, 860i and 880i Synchron Access Clinical Sys 의 리콜

Recall

63191

Class 2

Z-0059-2013

2012-07-06

2012-10-12

Terminated

United States

2012-11-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112909

The recall was initiated because beckman coulter has confirmed that the current sample syringe pump drive assemblies installed on dxc integrated ystem with unicel closted tube aliquotter (ucta) serial numbers between 547 and 574 may cause a hardware motion error (id0x08000501).

The recall notification was initiated on July 6, 2012 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form to all customers who purchased the UniCel DxC 880i, UniCel DxC 860i, UniCel 680i, UniCel DxC 660i Clinical System Integrated Workstations UCTA Sample Syringe Pump Drive Assembly. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Beckman Coulter will schedule a Service Call to replace the affected sample syringe pump drive assemblies. Customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any questions regarding the PCA, were instructed to call Customer Support at (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact Beckman Coulter Representative.