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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Dimension(R) Creatinine Flex(R) Reagent Cartridges see related information
Date Initiated by Firm December 27, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on December 21, 2013
Recall Number Z-1729-2011
Recall Event ID 57631
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 - Lots BB1286, CA1260 and FB1251
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		 Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well that has been punctured. This issue may affect creatinine results for quality control (QC) and patient samples.
FDA Determined
Cause 2		 Material/Component Contamination
Action The firm, SIEMENS, sent an "Urgent Field Safety Notice" dated December 2010 to all customers. The letter described the product ( Dimension(R) CREA Flex(R) Reagent Cartridges DF33A lots BB1286, CA1260 and FB1251), problem and actions to be taken. The customers were instructed to please discontinue use and discard any remaining inventory of the product; complete and return the fax form to the Customer Service Support for replacement of the product; if they must continue use of the product until they receive a replacement, open a new well set every 8 hours to minimize any impact to CREA test results, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to the Technical Solution Center at 302-631-8467. If you have any questions, contact the Technical Solution Center at 800-441-9250.
Quantity in Commerce 20,177
Distribution Worldwide distribution: United States and the following foreign countries: Austria, Belgium, Bosnia and Herzegovina, Canary Islands, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Great Britain, Greece, Hungary, Italy, Latvia, Lithuania, Kuwait, Macedonia, Morocco, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey and the United Arab Emirates.
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.
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