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U.S. Department of Health and Human Services

Class 1 Device Recall Synchron LXi 725

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  Class 1 Device Recall Synchron LXi 725 see related information
Date Initiated by Firm April 05, 2011
Date Posted May 06, 2011
Recall Status1 Terminated 3 on February 06, 2013
Recall Number Z-2132-2011
Recall Event ID 58567
510(K)Number K023049  
Product Classification Discrete Photometric Chemistry Analyzer for Clinical Use - Product Code JJE
Product Synchron LXi 725, Part Number: 476501.

Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
Code Information All Serial Numbers.  
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 received reports of incorrect electrolyte results on Synchron LX systems due to a variety of maintenance-related hardware issues.
FDA Determined
Cause 2		 Equipment maintenance
Action The recall communication was initiated on 04/05/2011 with Beckman Coulter forwarding a Product Correction letter with attached customer response form to the affected customers via US Postal Service. The letter informed customers of the products affected, the issue, the impact, and the actions to be taken. Customers were instructed to follow the steps provided in order to address the issues related to microbial contamination; and to complete and return the enclosed response form within 10 days so that receipt of this important information could be confirmed. In addition, the letter requested customers share the information with their laboratory staff and retain the notification as part of your laboratory Quality System documentation. For customers who have any questions regarding this update, the letter indicated to contact Customer Support Center Call Center via the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/. They may also contact Beckman Coulter at (800) 854-3633 in the United States and Canada or through your local Beckman Coulter representative. Beckman Coulter will issue two additional recall notification ("UPDATE TO URGENT PRODUCT CORRECTION Synchron LX20, LX20 PRO, LXi 725 Clinical Systems") beginning on 05/20/2011, one to Laboratory Directors and one to Physicians. The notices will be mailed via US Postal Service on Friday, May 20th. Customers who have subscribed to email notifications will receive an email containing the letters on Monday, May 23th. Both letter informs the Laboratory Directors and Physicians that Beckman Coulter has received reports of erroneous/aberrant sodium, potassium, chloride and calcium results that have been released from the laboratory. Electrolyte shifts can be low or high and may occur above, below or within the normal range. Laboratory Directors were instructed to immediately disseminate the Attachment to this letter (via notification/alert procedure appropriate to your
Quantity in Commerce 1284 units total for all products
Distribution Worldwide Distribution -- Australia, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Hong Kong, India, Ireland, Italy, Japan, Republic of Korea, Kuwait, Mexico, Netherlands, Oman, Panama, Philippines, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.
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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