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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmDecember 16, 2002
Date PostedFebruary 05, 2003
Recall Status1 Terminated 3 on December 01, 2004
Recall NumberZ-0545-03
Recall Event ID 25359
510(K)NumberK011213 K014034 K965240 
Product Classification Electrode, Ion Specific, Sodium - Product Code JGS
ProductSYNCHRON LX20 AND LX20 Pro
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information ContactLynne McBride
714-993-5321
Manufacturer Reason
for Recall		The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.
FDA Determined
Cause 2		Other
ActionFirm will inspect instruments for failure conditions and fix the problem.
Quantity in Commerce1001
DistributionCanada and USA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JGS
510(K)s with Product Code = JGS
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