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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Flex Reagent Cartridge Cardiac TropininI

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  Class 2 Device Recall Dimension Flex Reagent Cartridge Cardiac TropininI see related information
Date Initiated by Firm March 02, 2007
Date Posted February 25, 2010
Recall Status1 Terminated 3 on February 25, 2010
Recall Number Z-0858-2010
Recall Event ID 53026
510(K)Number K010313  
Product Classification Troponin Subunit Immunoassay Method - Product Code MMI
Product Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521.

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 stratification of patients with acute coronary syndromes with respect to their relative risk or mortality.
Code Information Lot numbers: GF7353 exp 12/19/07, FF7362 exp 12/28/07, and GE7353 exp 12/19/07.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Customer Service Center
800-241-0420
Manufacturer Reason
for Recall		 Tests exhibit falsely elevated results.
FDA Determined
Cause 2		 Material/Component Contamination
Action The recalling firm issued a Field Correction letter dated 3/2/07 informing user of the problem and to contact the firm at 800-241-0420 for replacements. Customers are to follow the precautions provided in the letter. Questions should be directed to Dade Behring Technical Assistance Center at 800-441-9250. The notification should be forwarded to anyone to whom the product may have been further distributed to.
Quantity in Commerce 9767 cartons
Distribution Worldwide Distribution -- USA, Canada, Germany, Egypt, New Zealand, Saudi Arabia, Singapore, and BS.
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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