Events

Recall of ADVIA Centaur PSA Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74917
  • Event Risk Class
    Class 2
  • Event Number
    Z-2742-2016
  • Event Initiated Date
    2016-08-09
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148778
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prostate-specific antigen (psa) for management of prostate cancers - Product Code LTJ
  • Reason
    Communication provided to emphasize that the psa values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
  • 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.

Device

ADVIA Centaur PSA Assay
  • Model / Serial
    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
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA