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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista/Blood Urea Nitrogen Flex/BUN

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  Class 2 Device Recall Dimension Vista/Blood Urea Nitrogen Flex/BUN see related information
Date Initiated by Firm February 16, 2016
Create Date May 06, 2016
Recall Status1 Terminated 3 on December 01, 2017
Recall Number Z-1622-2016
Recall Event ID 73592
510(K)Number K051087  
Product Classification Urease and glutamic dehydrogenase, urea nitrogen - Product Code CDQ
Product Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge

The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
Code Information Device Listing # D011374, Lot # 15341AC, 15320BB, 15300BA, 15299BB, 15264BA, 15243BB and 15215AE
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Richard Andersen
302-631-0528
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens Healthcare sent an Urgent Medical Device Correction letter dated February 2016, to all affected customers. It was determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15299BB, 15300BA, 15320BB and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagent cartridges manufacture from specific mold/cavity identifies as described in Table 2 of the Urgent Medical Device Correction notification sent to customers. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (302) 631-0528.
Quantity in Commerce 18668 units
Distribution Worldwide distribution - US (nationwide) distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DC, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. , and to the countries of : Canada, United Arab Emir, Australia, Austria, Belgium, Switzerland, Bahamas, Czech Republic, Germany, Denmark, Spain, Finland, France, Italy, Netherland, Norway, Portugal, Slovakia, Slovenia, Japan, Republic of Korea, New Zealand.
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 = CDQ and Original Applicant = DADE BEHRING, INC.
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