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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA Centaur iPTH Calibrator

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 Class 2 Recall
Siemens ADVIA Centaur iPTH Calibrator
see related information
Date Posted June 06, 2013
Recall Status1 Open
Recall Number Z-1515-2013
Recall Event ID 65224
Premarket Notification
510(K) Number
K020217 
Product Classification Calibrator, Secondary - Product Code JIT
Product ADVIA Centaur® iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Code Information Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk 61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012 REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 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 198 (6 pk)
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 = JIT and Original Applicant = BAYER DIAGNOSTICS CORP.
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