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Class 3 Device Recall Dimension Vista(R) VANC Flex(R) Reagent Cartridge |
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Date Initiated by Firm |
July 17, 2012 |
Date Posted |
August 09, 2012 |
Recall Status1 |
Terminated 3 on January 14, 2014 |
Recall Number |
Z-2175-2012 |
Recall Event ID |
62609 |
510(K)Number |
K061655
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Product Classification |
Radioimmunoassay, vancomycin - Product Code LEH
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Product |
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086).
For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system. |
Code Information |
lot 12095AD, exp 2013-04-04 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, Mailstop 514 PO BOX 6101 Newark DE 19714-6101
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For Additional Information Contact |
302-631-6311
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Manufacturer Reason for Recall |
Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm initiated their recall of this product on July 17, 2012 by sending an Urgent Field Safety Notification via FedEx next day delivery to all consignees. The Notice informed consignees of the high calibration slopes with the affected device. Affected consignees were requested to immediately discontinue use and discard any remaining Dimension Vista(R) VANC Flex(R) reagent cartridges, lot 12095AD. Affected customers were provided with replacement cartridges. Customers were to also complete the attached form and fax it back to the number provided. The notification letter should be forwarded to anyone, whom customers may have further distributed the affected lot. Questions and concerns should be directed to Siemens Technical Solutions Center at 800-441-9250. |
Quantity in Commerce |
1,894 cartons |
Distribution |
Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LEH and Original Applicant = DADE BEHRING, INC.
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