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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista VLYTE Fluids Standard B/Salt Brige

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  Class 2 Device Recall Dimension Vista VLYTE Fluids Standard B/Salt Brige see related information
Date Initiated by Firm October 22, 2009
Date Posted March 10, 2010
Recall Status1 Terminated 3 on December 16, 2010
Recall Number Z-1038-2010
Recall Event ID 53686
510(K)Number K051087  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825
Code Information Catalog number K825
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Technical Solutions Center
800-441-9250
Manufacturer Reason
for Recall		 Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.
FDA Determined
Cause 2		 Other
Action The recalling firm issued an Urgent Field Safety Notice dated October 2009 to all affected customers. Customers were given instruction which minimize urine specimen use and report urine specimen results when QC is acceptable. Sensors are to be replaced when urine QC is out. Replacement sensors are available by contacting the firm at 800-241-0420. Please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.
Quantity in Commerce 150 units
Distribution The product was shipped to medical facilities nationwide. The product was also shipped to Australia, Canada, Belgium, France, Germany, Italy, Japan, Malaysia, New Zealand, Netherlands, Portugal, Spain, South Korea, and Switzerland.
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 = DADE BEHRING, INC.
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