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

• Date Initiated by Firm: June 10, 2010
• Date Posted: May 10, 2011
• Recall Status: Terminated 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: 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