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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 Device Recall Siemens ADVIA Centaur iPTH Calibrator see related information
Date Initiated by Firm May 14, 2013
Date Posted June 06, 2013
Recall Status1 Terminated 3 on March 05, 2015
Recall Number Z-1515-2013
Recall Event ID 65224
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 MA 02032-1516
For Additional Information Contact
508-668-5000
Manufacturer Reason
for Recall		 iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
FDA Determined
Cause 2		 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 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 = JIT and Original Applicant = BAYER DIAGNOSTICS CORP.
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