• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA Centaur iPTH Calibrator

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
 Class 2 Device Recall Siemens ADVIA Centaur iPTH Calibrator see related information
Date Posted June 06, 2013
Recall Status1 Terminated on March 05, 2015
Recall Number Z-1514-2013
Recall Event ID 65224
510(K)Number K020217 
Product Classification Calibrator, secondary - Product Code JIT
Product ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394.

For in vitro diagnostic use in calibrating Intact PTH assays.
Code Information Calibrator Lot Number: C5601 and C5602
Kit Lot Number/Exp. Date:
61405A01 27 Oct 2011
66517A02 27 Oct 2011
66611A02 27 Oct 2011
71997C02 27 Oct 2011
Recalling Firm/
Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
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 99 (2 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.