Events

Recall of Device Recall Siemens ADVIA Centaur MultiDiluent 1

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
    62702
  • Event Risk Class
    Class 2
  • Event Number
    Z-2313-2012
  • Event Initiated Date
    2012-07-25
  • Event Date Posted
    2012-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111446
  • 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
    Test,natriuretic peptide - Product Code NBC
  • Reason
    Decrease in onboard dilution recovery when using multi-diluent 1 that has been stored on board the advia centaur and advia centaur xp systems for for bnp and tsh3 ultra assays.
  • Action
    Siemens sent an "URGENT DEVICE RECALL NOTICE" dated July 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Response Form was included for customers to complete and return via fax to (302) 631-7597. Contact your local Sales Representative for questions regarding this notice.

Device

Device Recall Siemens ADVIA Centaur MultiDiluent 1
  • Model / Serial
    Lot # Expiry Date 2 Pack 76129 22 JUN 2012  77542 22 JUN 2012  78696 22 JUN 2012  80828 26 SEP 2012  80857 26 SEP 2012  81441 26 SEP 2012  82189 26 SEP 2012  83647 26 SEP 2012  84772 26 SEP 2012  86037 13 JAN 2013  86783 13 JAN 2013  88712 13 JAN 2013  90056 13 JAN 2013  91002 13 JAN 2013  93126 13 JAN 2013  6 Pack 76102 22 JUN 2012  76432 22 JUN 2012  77075 22 JUN 2012  78264 22 JUN 2012  79037 22 JUN 2012  81006 26 SEP 2012  82539 26 SEP 2012  83321 26 SEP 2012  84123 26 SEP 2012  85795 13 JAN 2013  86698 13 JAN 2013  88318 13 JAN 2013  89286 13 JAN 2013  90490 13 JAN 2013  91672 13 JAN 2013  93129 13 JAN 2013
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Australia, Brazil, Chile, China, Croatia, Denmark, Ecuduar, Egypt,Guatemala, Hong Kong,India,Ireland, Israel,India, Japan,Korea, Mexico, Malyasia, Peru, Pakistan, Saudi Arabia,Singapore, Thailand,Uruguay, Viet Nam, and South Africa.
  • Product Description
    Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. || Catalog Numbers: || 2 Pack REF 07907174 (110312) || 6 Pack REF 07293184 (110313). || Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
  • 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