Class 2 Device Recall Siemens ADVIA Centaur iPTH ReadyPack Assay

• Date Initiated by Firm: May 14, 2013
• Date Posted: June 06, 2013
• Recall Status: Terminated on March 05, 2015
• Recall Number: Z-1512-2013
• Recall Event ID: 65224
• 510(K)Number: K121981
• Product Classification: Radioimmunoassay, parathyroid hormone - Product Code CEW
• Product: ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
• Code Information: Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 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: 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: 309 (100 test) kits
• 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 = CEW