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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 63605
Product Type Devices
Status Ongoing
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Israel, Australia, India, United Kingdom, Netherlands, Malaysia, Russian Federation, Japan, Taiwan, and Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories. Models, Catalogue Numbers: AU5811-01, A94906; AU5811-02, A94907; AU5811-03, A94908; AU5811-04, A94909; AU5811-06, A94910; AU5821-01, A94911; AU5821-02, A94912; AU5821-03, A94913; AU5821-04, A94914; AU5821-06, A94915; AU5831-01, A94916; AU5831-02, A94917; AU5831-03, A94918; AU5831-04 A94919; AU5831-06 A94920; AU5831-01 A94921; AU5831-02 A94922; AU5831-03 A94923; AU5831-04 A94924; AU5831-06 A94925. Class II Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve. 338 units (11 units in the US) Z-1873-2013