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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista VLYTE Standard A

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  Class 2 Device Recall Dimension Vista VLYTE Standard A see related information
Date Initiated by Firm August 19, 2010
Date Posted October 25, 2010
Recall Status1 Terminated 3 on October 26, 2010
Recall Number Z-0139-2011
Recall Event ID 56703
510(K)Number K051087  
Product Classification Electrode, ion specific potassium - Product Code CEM
Product Dimension Vista V-LYTE Standard A, Catalog No K820
For the calibration of Na+/K+/Cl- on the Dimension vista System.
Code Information KA0C03 EXP 3/24/11, KA0D01 EXP 4/14/11, KA0E01 EXP 5/5/11, KA0E02 EXP 5/19/11, KA0F01 EXP 6/3/11, AND KA0G01 EXP 7/8/11
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Aydee Crawford
302-631-6311
Manufacturer Reason
for Recall		 High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.
FDA Determined
Cause 2		 Other
Action Siemens sent an Urgent Field Safety Notice (dated "August 2010") to customers identifying the product, the problem and the action to be taken. Customers were instructed on how to continue testing until new lots of the recalled product were available and asked to complete and fax a Field Correction Effectiveness Check to 301-631-8467 to confirm receipt of the Urgent Field Safety Notice. For technical questions or concerns customers were instructed to contact the Siemens Technical Solutions Center at 800-441-9250.
Quantity in Commerce 3,706 cartons
Distribution USA, Nationwide Distribution
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 = CEM and Original Applicant = DADE BEHRING, INC.
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