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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension(R) Vista(R) VLYTE(R)

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  Class 2 Device Recall Dimension(R) Vista(R) VLYTE(R) see related information
Date Initiated by Firm October 31, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-0644-2012
Recall Event ID 60644
510(K)Number K051087  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Dimension(R) Vista(R) V-LYTE(R) Standard A (K820)

Product Usage: V-LYTE(R) Standard A is for the calibration of NA, K, and CL on the Dimension Vista(R) system
Code Information Lot number KA1G01, KA1H01, and KA1J01
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Robert J. King
302-631-0516
Manufacturer Reason
for Recall		 Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IMT sensor. The results can be elevated approximately 10-20% which may cause QC recovery being out of acceptable ranges. Patient Urine sodium results may also b
FDA Determined
Cause 2		 Material/Component Contamination
Action Siemens sent an Urgent Field Safety Notice letter dated October, 2011 to all consignees. The letter identified the product, description of problem, and actions to be taken. Consignees were instructed to replace the affected lots of V-LYTE(R) Fluids with alternate lots if available and recalibrate. If no alternate lots were available they were recommended to replace the V-LYTE(R) Integrated Multisensor every 24 hours or when indicated by QC until the impacted lots were no longer in use. For replacement product consignees were instructed to contact the Siemens Customer Service at 888-588-3916 or your local Siemens Service Center. Consignees were advised to complete and return the enclosed Customer Response Sheet via fax to the Technical Solutions Center at 302-631-8467. For questions or concerns contact Siemens Technical Solutions Center at 800-441-9250 for further assistance.
Quantity in Commerce 6,000
Distribution Worldwide Distribution - USA (nationwide) iin the states of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MS, MO, MT, NE, NH, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, VT, UT, VA, WA, WV, WI, WY including Puerto Rico and Washington, DC and the countries of: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Canada, Australia, Japan, New Zealand, Malaysia, and South Korea.
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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