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Class 2 Device Recall Dimension Vista(R) Cardiac Troponin I Calibrator |
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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
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Product Classification |
troponin in vitro diagnostic - Product Code JIT
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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
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For Additional Information Contact |
Robert J. King 302-631-0516
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Manufacturer Reason for Recall |
Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.
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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
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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.
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510(K) Database |
510(K)s with Product Code = JIT and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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