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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems

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 Class 2 Recall
Access Immunoassay Systems
see related information
Date Posted April 01, 2013
Recall Status1 Terminated on December 23, 2013
Recall Number Z-1035-2013
Recall Event ID 64332
Premarket Notification
510(K) Numbers
K023049  K060256 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Code Information Part # A25640, A25638, A25656, A25637; All Serial Numbers
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
For Additional Information Contact Yung (Dung) Nguyen
714-961-4941
Manufacturer Reason
for Recall
Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
FDA Determined
Cause 2
DESIGN: Device Design
Action Beckman Coulter sent an "Urgent Product Correction" letter dated February 12, 2013 via mail and email to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to place your Access system in the Ready or Not Ready mode. Lift the cover (as you do to access the probes) and look at the left side of the incubator unit under the peripump by the aspirate probe, if you see a silver pulley, immediately discontinue use and contact Technical Support also check for QC failures and system check failures; If you see a white pulley, this is the correct part and you can resume normal activity. Beckman will replace the metal pulley with the plastic pulley if you verified the your instrument has the silver pulley. The customers were also instructed to share this information with staff; and complete and return enclosed Response Form within 10 days. If you have any questions regarding this notice, please contact Technical support from the website: http://www.beckmancoulter.com or by phone at: 1-800-854-3633 in the United States and Canada.
Quantity in Commerce 956 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
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 = BECKMAN COULTER, INC.
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