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U.S. Department of Health and Human Services

Class 2 Device Recall AU5800 Clinical Chemistry Analyzer

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  Class 2 Device Recall AU5800 Clinical Chemistry Analyzer see related information
Date Initiated by Firm June 03, 2013
Date Posted July 31, 2013
Recall Status1 Terminated 3 on August 23, 2014
Recall Number Z-1834-2013
Recall Event ID 65440
510(K)Number K112412  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
Code Information Model Numbers: AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06  Part Numbers: A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925  Serial Numbers: All
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall		 The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
FDA Determined
Cause 2		 Software design
Action An Urgent Product Correction letter dated 5/29/13 was sent on the week of June 3, 2013 to all the customers who received the AU5800 Clinical Chemistry Analyzer with Automation Ready (AR) Connection (All Software versions). The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to complete and return the enclosed Response Form within 10 days and to share the information with their laboratory staff. Customers with questions are instructed to contact the 24 hours Call Center (Hotline) at (800) 854-3633 in the US and Canada.
Quantity in Commerce 76 units
Distribution Worldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands.
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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