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U.S. Department of Health and Human Services

Class 2 Device Recall AU2700 and AU5400 Clinical Chemistry Analyzers

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 Class 2 Device Recall AU2700 and AU5400 Clinical Chemistry Analyzers see related information
Date Posted May 29, 2013
Recall Status1 Terminated on August 04, 2014
Recall Number Z-1430-2013
Recall Event ID 65118
510(K)Number K003721  K011720 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product AU2700 Clinical Chemistry Analyzer
AU5400 Clinical Chemistry Analyzer

Perform automated analysis of serum, urine, and other body fluids, including whole blood.
Code Information 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
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Component design/selection
Action Beckman Coulter sent an Urgent Product Correction letter on April 26, 2013 along with a response form. The letter notified customers of the product, problem, and actions to be taken by the customers. Contact the Call Center at 800-854-3633 for questions regarding this notice.
Quantity in Commerce 108 units
Distribution Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = OLYMPUS AMERICA, INC.
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