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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter AU480, AU680, AU5800, and AU5400 Clinical Analyzers

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  Class 2 Device Recall Beckman Coulter AU480, AU680, AU5800, and AU5400 Clinical Analyzers see related information
Date Initiated by Firm September 09, 2013
Date Posted November 05, 2013
Recall Status1 Terminated 3 on September 30, 2014
Recall Number Z-0153-2014
Recall Event ID 66253
510(K)Number K981743  K961274  K112412  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer.

Automated chemistry analyzers that measures analytes in samples.
Code Information AU480, Item Code: N3151200 N3151300 N3151400 N3151500 N3151600 N3151700 N3151800 N3151900 N3659600 N3659700 N3659900 N3660000 N3660200 N3660400 N3660600 N3660800 N3912500  AU480 OPA, Item Code: B11803 N3152300 N3152400 N3152500 N3152600 N3912600  AU680, Item Code: B12184 B12185 B12187 B12188 N3147100 N3147200 N3147300 N3147400 N3147500 N3148100 N3149800 N3153300 N3153700 N3153800 N3154000 N3658100 N3662100 N3662200 N3662400 N3662900 N3663000 N3910100 N3910400 N3910500 N3910800 N3910900 N3911200 N3911300 N3911900  AU680 OPA:  B11474 N3148300 N3148600 N3148700 N3150500 N3912700   AU5800 OPA, Item Code:  A94927 A94928 A94929 A94930 N9028030 
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Clair K. ODonovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall
The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.
FDA Determined
Cause 2
Nonconforming Material/Component
Action A customer notification letter dated 9/9/13 was sent to customers who received the ISE REF Valve, Part Number MU3226 for the AU400, AU640, AU2700, AU5400 and the ISE REF Valve, Part Number MU7638 for the AU480, AU680, AU5800 Chemistry Analyzers. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter Customer Support Center via http://www.beckmancoulter.com/customersupport/support, via phone at (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 4584 units total (1173 units in US)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe.
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.
510(K)s with Product Code = JJE and Original Applicant = OLYMPUS AMERICA, INC.
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