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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Cardiac Troponin I Flex reagent cartridge

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  Class 2 Device Recall Dimension Cardiac Troponin I Flex reagent cartridge see related information
Date Initiated by Firm April 08, 2008
Date Posted August 12, 2009
Recall Status1 Terminated 3 on August 13, 2009
Recall Number Z-1731-2009
Recall Event ID 51998
510(K)Number K010313  
Product Classification Immunoassay method, troponin subunit - Product Code MMI
Product Dimension Cardiac Troponin I Flex reagent cartridge (CTNI).

The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Code Information Catalog Number: RF421C; Lot Number: FB9037. Expires February 6, 2009.
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 Center
800-441-9250
Manufacturer Reason
for Recall		 possibility of falsely elevated results
FDA Determined
Cause 2		 Process control
Action Siemens Healthcare Diagnostics issued a letter to their customers starting April 8, 2008 informing them of the problem and to discontinue use of the product. Further questions should be addressed to Siemens Healthcare Diagnostics, Inc. at 1-800-441-9250.
Quantity in Commerce 4,574 cartons
Distribution Worldwide Distribution -- Including countries of the United States, Bahamas, Belgium, Czech Republic, France, Germany, Italy, Poland, Portugal, Saudi Arabia, Spain, South Korea, and Slovakia.
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 = MMI and Original Applicant = DADE BEHRING, INC.
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