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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista(R) Cardiac Troponin I Calibrator

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  Class 2 Device Recall Dimension Vista(R) Cardiac Troponin I Calibrator see related information
Date Initiated by Firm November 17, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on August 26, 2014
Recall Number Z-0513-2012
Recall Event ID 60643
510(K)Number K081683  
Product Classification troponin in vitro diagnostic - Product Code JIT
Product Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
Code Information Lot number 1DD085
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		 Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens healthcare Diagnostics initiated their recall of lot 1DD085 on November 17, 2011 by sending an Urgent Field Safety Notice letter to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the CTNI CAL lot 1DD085.
Quantity in Commerce 2281 cartons
Distribution Worldwide distribution, including USA, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Puerto Rico, Slovenia, South Korea, Spain and Switzerland.
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 = JIT and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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