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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107)

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 Class 2 Recall
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107)
see related information
Date Posted March 15, 2013
Recall Status1 Open
Recall Number Z-0957-2013
Recall Event ID 63767
Premarket Notification
510(K) Number
K060502 
Product Classification Enzyme Immunoassay, Tracrolimus - Product Code MLM
Product Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Code Information Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
Manufacturer Reason
for Recall
Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action The firm initiated their recall of this product on November 27, 2012 by sending a letter to all consignees. The letter included a recall effectiveness check form to be completed by the consignee and returned to the firm. The firm expanded their recall on January 29, 2013 by sending another letter to consignees. This letter also included a recall effectiveness check form to be completed by the consignee and returned to the firm.
Quantity in Commerce 2,976
Distribution Product was distributed within the United States to AL, AZ, CA, DC, FL, LA, MD, MI, MO, NJ, NM, NC, OH, OR, PA, TN, TX, UT, VA, and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MLM and Original Applicant = DADE BEHRING, INC.
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