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U.S. Department of Health and Human Services

Class 3 Device Recall ADVIA Centaur Intact PTH Calibrator

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  Class 3 Device Recall ADVIA Centaur Intact PTH Calibrator see related information
Date Initiated by Firm August 16, 2013
Date Posted November 06, 2013
Recall Status1 Terminated 3 on February 13, 2014
Recall Number Z-0173-2014
Recall Event ID 66132
510(K)Number K020217  
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
Product ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387

For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
Code Information Kit Lot: 14136A16 04 Mar 2014
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact Erin Hansen
508-668-5000
Manufacturer Reason
for Recall		 PTH Calibrator packaged with only high calibrator.
FDA Determined
Cause 2		 Packaging
Action Packaging error was brought to Siemens' attention through escalations received from (3) customers in the United States. Internal Investigation confirmed the issue was limited to the five (5) kits distributed to these customers. As the customers were aware of the issue and non affected product was provided to the customers to use during Siemens' investigation, no further communication was warranted.
Quantity in Commerce 595 kits total (5 kits with packaging error)
Distribution Nationwide Distribution including MD, PA, and CT.
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 = CEW and Original Applicant = BAYER DIAGNOSTICS CORP.
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