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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron LX20 Clinical Chemistry System

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  Class 2 Device Recall Synchron LX20 Clinical Chemistry System see related information
Date Initiated by Firm April 05, 2007
Date Posted May 24, 2008
Recall Status1 Terminated 3 on January 15, 2013
Recall Number Z-1094-2008
Recall Event ID 45960
510(K)Number K965240  
Product Classification Chemistry Analyzer (Discrete Photometric) - Product Code JJE
Product Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Beckman Coulter, Inc.
Code Information Part Numbers 466200,473032.  All serial numbers. All software versions.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall		 Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.
FDA Determined
Cause 2		 Software design
Action GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
Quantity in Commerce 344 in the US; 26 in Canada
Distribution Worldwide Distribution - USA including 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 INSTRUMENTS, INC.
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