Class 2 Device Recall Dimension(R) Creatinine Flex(R) Reagent Cartridges

• Date Initiated by Firm: November 22, 2011
• Date Posted: January 15, 2012
• Recall Status: Terminated on April 03, 2014
• Recall Number: Z-0772-2012
• Recall Event ID: 60618
• 510(K)Number: K925668
• Product Classification: Alkaline picrate, colorimetry, creatinine - Product Code CGX
• Product: Dimension(R) Creatinine Flex(R) Reagent Cartridges.; ; The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System.
• Code Information: Catalog number DF33A and lot numbers GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 GBC Drive, Mailstop 514; PO BOX 6101; Newark DE 19714-6101
• For Additional Information Contact: Robert J. King; 302-631-0516
• Manufacturer Reason for Recall: Siemens has confirmed the potential for falsely elevated creatinine results with CREA FLex(R) reagent cartridge lots GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237 when processing tests from a well that has been punctured.
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens sent an "URGENT FIELD SAFETY NOTICE" dated November 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter recommends that customers discontinue and discard any remaining inventory of the affected product. The firm also recommends customers to test QC at least every 8 hours with lots manufactured after lot FA2237. Additionally, a Field Correction Effectiveness Check form was attached to the letter for customers to complete and return via fax to 302-631-8467. Contact the Siemens Customer Service Center at 888-588-3916 for questions regarding this notice.
• Distribution: Worldwide Distribution-USA (nationwide) including the District of Columbia and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Benin, Bosnia Herzegovina, Botswana, Brazil, Canada, Canary Islands, Ceuta/Mililla, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, France, French Guinea, Germany, Great Britian, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxemburg, Macedonia, Mexico, Montenegro, Morocco, Nepal, Nether Antilles, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, Yemen and Zimbabwe.
• 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 = CGX and Original Applicant = E.I. DUPONT DE NEMOURS & CO., INC.