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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65118
Product Type Devices
Status Ongoing
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood. All Serial Numbers Model Numbers: AU2700, AU27000ISE, AU5421, AU5421ISE, AU5431. Part Numbers: E0750053 N3663400 N3663700 N3664000 N3664200 N3664400 N3664600 N3664800 N3878500 1465600 64270G E61DAU2700 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600 O9102700 N3665000 N3665100 N3665200 N3665300 N3665400 N3878300 64542 A94504 N1683100 AU5431-U1 N3665500 N3665600 N3665700 N3665800 N3665900 N3878400 Class II Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak. 108 units Z-1430-2013