ClearanceBrief
Recall Z-0059-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Beckman Coulter Inc.

Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro determination of a variety of general chemistries, therapeutic drugs, and other che

DateOct 12, 2012 (initiated Jul 6, 2012)
StatusTerminated
ReasonThe 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).
Root causeNonconforming Material/Component
ActionThe 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
Quantity18 units
DistributionWorldwide Distribution and US (nationwide) and the countries of China, France, Italy and Taiwan.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K042291UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
Beckman Coulter, Inc., Nov 12, 2004
K060256UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
Beckman Coulter, Inc., Feb 27, 2006
K103842UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
Beckman Coulter, Inc., Apr 27, 2011