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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085)

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  Class 2 Device Recall Siemens Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) see related information
Date Initiated by Firm October 08, 2012
Date Posted December 03, 2012
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-0452-2013
Recall Event ID 63429
510(K)Number K061793  
Product Classification Photometric method, iron (non-heme) - Product Code JIY
Product Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085)

The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
Code Information Lot numbers 11286BA, 11319BB, 12004BB, 12044BC, 12073BB, 12073BC, 12101BC, 12101BD, 12130BB, 12130BC and 12188BD.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. All lots of IRON Flex(R) reagent cartridges have the potential for this issue. If a well set is contaminated with trace amounts of iron, the entire well set is impacted, and the mag
FDA Determined
Cause 2		 Material/Component Contamination
Action The firm intiated their recall of the specified lots on October 8, 2012 by issuing a letter to all consignees informing them of the problems with the reagent cartridges. Firm recommended batching the processing of the tests on one instrument and provided instructions to disable normal flow of IRON and to run the QC on each IRON Flex(R) reagent cartridge well set. In addition, a a reply form and Frequently Asked Questions attachment were enclosed with the communication. For questions regarding this recall call 302-631-6311.
Quantity in Commerce 19,310
Distribution Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to Canada, AU, NZ, JP, DE, SA, and MY
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 = JIY and Original Applicant = DADE BEHRING, INC.
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