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U.S. Department of Health and Human Services

Class 3 Device Recall Dimension Flex Reagent Cartridge CReactive Protein Extended Range (RCRP)

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  Class 3 Device Recall Dimension Flex Reagent Cartridge CReactive Protein Extended Range (RCRP) see related information
Date Initiated by Firm April 15, 2008
Date Posted September 08, 2009
Recall Status1 Terminated 3 on September 09, 2009
Recall Number Z-1930-2009
Recall Event ID 52000
510(K)Number K003419  
Product Classification System, test, c-reactive protein - Product Code DCN
Product Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP).

In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Code Information Catalog Number DF34; Lot Numbers: CE8324 exp 11/19/2008, BA8349 exp 12/14/2008, FB9003 exp1/3/2009, BC9017 exp1/17/2009, EC9021 exp1/21/2009, DB9032 exp2/1/2009, and DC9045 exp2/14/2009.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Technical Solutions Center
800-441-9250
Manufacturer Reason
for Recall		 falsely elevated results in EDTA plasma samples
FDA Determined
Cause 2		 Labeling False and Misleading
Action Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice on April 15, 2008 informing their customers that the EDTA plasma specimen claim had been rescinded. Current lots in the firm's inventory have been put on hold and reworked with an Alert Card rescinding the EDTA plasma claim. Subsequent lots use a revised instruction for use stating "Do not use EDTA plasma" in the Specimen Collection and Handling Section. For further questions, contact Siemens Healthcare Diagnostics at 1-302-631-6564.
Quantity in Commerce 25,760 cartons
Distribution Worldwide Distribution -- US, Austria, Bosnia, Czech Republic, Hungary, Slovakia, Serbia, Denmark, Estonia, Latvia, Lithuania, Norway, Sweden, Belgium, Cyprus, Canary Islands, France, Great Britain, Germany, Ireland, Italy, Netherlands, Poland, Russia, Portugal, Saudi Arabia, Spain, South Africa, Switzerland, Turkey, Yemen, Bahamas, Brazil, Canada, Mexico, Australia, Bangladesh, China, Hong Kong, Japan, Malaysia, Pakistan, and Taiwan.
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 = DCN and Original Applicant = DADE BEHRING, INC.
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