Class 2 Device Recall ADVIA Centaur PSA Assay

• Date Initiated by Firm: August 09, 2016
• Create Date: September 07, 2016
• Recall Status: Terminated on January 06, 2020
• Recall Number: Z-2742-2016
• Recall Event ID: 74917
• PMA Number: P950021 P950021S003
• Product Classification: Prostate-specific antigen (psa) for management of prostate cancers - Product Code LTJ
• Product: ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
• Code Information: SMN 10310292 - 100 test kits Lot# UDI# 40776268 0063041420300340776268160922 53535268 0063041420300353535268160922 67015269 0063041420300367015269161124 72335269 00630414203003723352691611 24 82156270 0063041420300382156270161229 87504270 0063041420300387504270161229 93298271 0063041420300393298271170205 5702271 0063041420300305702271170205 17339271 006304142030031733927 11 70205 19110272 0063041420300319110272170418 27655272 0063041420300327655272170418 SMN 10310293- 500 test kits Lot# 39805268 50851268 60225269 71544269 81085270 86551270 93505271 7329271 16252272 24689272 33327272 UDI# 0063041420299039805268160922 0063041420299050851268160922 0063041420299060225269161124 0063041420299071544269161124 0063041420299081085270161229 0063041 420299086551270161229 0063041 420299093505271 170205 0063041420299007329271 170205 0063041420299016252272170418 0063041420299024689272170418 0063041420299033327272170418
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc; 333 Coney St; East Walpole MA 02032-1516
• For Additional Information Contact: Louise McLaughlin; 508-668-5000
• Manufacturer Reason for Recall: Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
• FDA Determined Cause: Under Investigation by firm
• Action: An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 29, 2016 to be delivered to customers on August 1, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 28, 2016. These emphasize that the prostate specific antigen (PSA) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy (e.g., the 2013 American Urological Association (AUA) Guidelines or the 2015 European Association of Urology (EAU)). These guidelines define biochemical recurrence of prostate cancer as a detectable or rising PSA value post-radical prostatectomy that is > or = 0.2 ng/mL (ug/L) with a second confirmatory level of > or = 0.2 ng/mL (ug/L). The communications also provide functional sensitivity from a recent study to give an expectation of precision at the low end of the assay.
• Distribution: Nationwide Albania Algeria Angola Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France Georgia Germany Great Britain Greece Hungary Iceland Iraq Italy Jordan Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Netherlands Norway Pakistan Poland Portugal Qatar Romania Russian Fed. Senegal Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey Unit.Arab Emir. Uzbekistan Vatican
• 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.

• PMA Database: PMAs with Product Code = LTJ and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS