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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter AU5800 Clinical Chemistry Analyzer

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  Class 2 Device Recall Beckman Coulter AU5800 Clinical Chemistry Analyzer see related information
Date Initiated by Firm October 26, 2012
Date Posted August 02, 2013
Recall Status1 Terminated 3 on October 18, 2013
Recall Number Z-1873-2013
Recall Event ID 63605
510(K)Number K112412  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical - Product Code JJE
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action A recall notification letter was forwarded to all their customers on 11/1/12 who purchased the AU5800 Clinical Chemistry Analyzer. The customers were informed of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Reponse form within 10 days. Customers with questions are instructed to call (800) 854-3633 or contact their local BCI Representative.
Quantity in Commerce 338 units (11 units in the US)
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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