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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Event Detail

Event ID 68309
Product Type Devices
Status Ongoing
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-14
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems. Access 2 Immunoassay Systems, Catalog Number: 81600N. UniCel DxI 600 Access Immunoassay Systems, Catalog Numbers: A30260 and A71460. UniCel DxI 800 Access Immunoassay Systems, Catalog Numbers: 973100 and A71456. UniCel DxC 600i SYNCHRON Access Clinical Systems, Catalog Number: A25640. Catalog numbers for these systems are included in the respective DxI 600 and DxI 800 model numbers: UniCel DxC 660i SYNCHRON Access Clinical Systems, UniCel DxC 680i SYNCHRON Access Clinical Systems, UniCel DxC 860i SYNCHRON Access Clinical Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. Class II Beckman Coulter is initiating a field action for the Access Family of Immunoassay Systems because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws. 82 units Z-1737-2014
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