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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 Calibratorsee related information
Date Initiated by FirmAugust 16, 2013
Date PostedNovember 06, 2013
Recall Status1 Terminated 3 on February 13, 2014
Recall NumberZ-0173-2014
Recall Event ID 66132
510(K)NumberK020217 
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
ProductADVIA 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
FEI Number 1219913
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information ContactErin Hansen
508-668-5000
Manufacturer Reason
for Recall		PTH Calibrator packaged with only high calibrator.
FDA Determined
Cause 2		Packaging
ActionPackaging 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 Commerce595 kits total (5 kits with packaging error)
DistributionNationwide Distribution including MD, PA, and CT.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CEW
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