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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA Centaur iPTH ReadyPack Assay

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 Class 2 Recall
Siemens ADVIA Centaur iPTH ReadyPack Assay
see related information
Date Posted June 06, 2013
Recall Status1 Open
Recall Number Z-1513-2013
Recall Event ID 65224
Premarket Notification
510(K) Number
K121981 
Product Classification Radioimmunoassay, Parathyroid Hormone - Product Code CEW
Product ADVIA Centaur® iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Code Information Reagent Lot Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 REF 10493616-500 Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 09 Nov 2011
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole, Massachusetts 02032-1516
Manufacturer Reason
for Recall
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action Siemens sent an Urgent Medical Device Correction letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions, contact your Siemens Technical Solutions Center or your local Siemens technical support.
Quantity in Commerce 3302 Kits (500 test)
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CEW and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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