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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension(R) EZCR Flex(R) Reagent Cartridge

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  Class 2 Device Recall Dimension(R) EZCR Flex(R) Reagent Cartridge see related information
Date Initiated by Firm June 10, 2010
Date Posted May 10, 2011
Recall Status1 Terminated 3 on March 19, 2013
Recall Number Z-2177-2011
Recall Event ID 58380
510(K)Number K073055  
Product Classification creatinine test in vitro diagnostic - Product Code JFY
Product Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System.
Code Information Catalog number DF270B - Lot numbers BD1008, CD1050, FA1081 and GA1190.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Aydee Crawford
302-631-6299
Manufacturer Reason
for Recall		 Patient results may be falsely depressed or falsely elevated across the assay range.
FDA Determined
Cause 2		 Device Design
Action Siemens issued an Urgent Field Safety Notice dated June 2010 to all Dimension(R) EZCR customers; to notify them that Siemens confirmed an issue which many cause EZCR results to be falsely depressed or falsely elevated across the assay range. The letter asks users to discontinue use of this lab test kit.
Quantity in Commerce 860
Distribution Nationwide distribution.
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 = JFY and Original Applicant = DADE BEHRING, INC.
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