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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista ECREA Flex Reagent Cartridge

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  Class 2 Device Recall Dimension Vista ECREA Flex Reagent Cartridge see related information
Date Initiated by Firm February 12, 2010
Date Posted September 16, 2010
Recall Status1 Terminated 3 on October 13, 2010
Recall Number Z-2419-2010
Recall Event ID 54682
510(K)Number K090330  
Product Classification enzymatic method, creatinine - Product Code JFY
Product Dimension Vista ECREA Flex Reagent Cartridge
The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista 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 Catalog number K1270. Lot number 09224AA
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Technical Solutions
800-441-9250
Manufacturer Reason
for Recall		 The ECREA test results may be falsely elevated or depressed.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent an Urgent Field Safety Notice dated February 2010 to all affected customers. The letter described the product, the problem, and the action to be taken by the customers. The customers were instructed to immediately discontinue the use of and discard the ECREA Flex reagent cartridge lot 09224AA. Customers are to contact their Siemens Customer Service Center at 800-241-0420 to report their additional no-charge replacement needs, and complete and return the enclosed Field Correction Effectiveness Check Form via Fax at 302-631-8467. For any technical questions regarding this Recall contact Siemens Technical Solutions Center at 800-441-9250.
Quantity in Commerce 324
Distribution Worldwide Distribution - USA, including the states of AZ, CA, FL, IA, IL, MT, NC, NY, OR, PA, TX, and WI and countries of Belgium, Italy, Canada, Germany and the Netherlands.
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 = Siemens Healthcare Diagnostics Inc.
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