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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista(R) MG Flex(R) Reagent Cartridge

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  Class 2 Device Recall Dimension Vista(R) MG Flex(R) Reagent Cartridge see related information
Date Initiated by Firm February 17, 2012
Date Posted April 17, 2012
Recall Status1 Terminated 3 on March 10, 2015
Recall Number Z-1433-2012
Recall Event ID 61465
510(K)Number K061655  
Product Classification Photometric method, magnesium - Product Code JGJ
Product Dimension Vista(R) MG Flex(R) Reagent Cartridge

The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System
Code Information Lot numbers 11263AC, 11286AB, 11306BA, 11332AB, 11332AC and 12010AB.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Customer Support
302-631-6299
Manufacturer Reason
for Recall		 Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent an Urgent Field Safety Notification letter dated February 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter explained the correction needed and instructed customers to forward the letter to anyone they may have distributed the affected product. For questions or concerns call 800-441--9250. For questions regarding this recall call 301-631-6299.
Quantity in Commerce 9,178
Distribution Nationwide Distribution including Puerto Rico and within the US to Washington, DC and the following States: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.
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 = JGJ and Original Applicant = DADE BEHRING, INC.
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