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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Enzymatic Creatinine Flex reagent cartridge

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  Class 2 Device Recall Dimension Enzymatic Creatinine Flex reagent cartridge see related information
Date Initiated by Firm September 29, 2008
Date Posted December 13, 2008
Recall Status1 Terminated 3 on March 27, 2009
Recall Number Z-0485-2009
Recall Event ID 50075
510(K)Number K073055  
Product Classification Creatinine enzymatic method - Product Code JFY
Product Dimension Enzymatic Creatinine Flex reagent cartridge, DF270.


The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
Code Information Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062, GA9043, GD9069, and GD9087.
Recalling Firm/
Manufacturer		 Dade Behring, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Elaine Kindell
302-631-6311
Manufacturer Reason
for Recall		 Reagent may exhibit unflagged inaccurate patient sample results.
FDA Determined
Cause 2		 Component design/selection
Action The recalling firm telephoned all customers on 9/29/08 to inform them of the problem. Customers were issued a letter dated 9/29/08 (and a response form) with instructions. Customers were instructed to complete the response form and fax (302-631-7242) it to Siemens Healthcare Diagnostics. For questions or additional information, contact the Siemens Technical Solutions Center at 800-441-9250.
Quantity in Commerce 12,773 cartons
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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