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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Event Detail

Event ID 63191
Product Type Devices
Status Ongoing
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-06
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution and US (nationwide) and the countries of China, France, Italy and Taiwan.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent). Serial Numbers: 547-574 (UCTA) Class II 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). 18 units Z-0059-2013
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