Events

Recall of Device Recall ADVIA Centaur Cyclosporine

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
    79505
  • Event Risk Class
    Class 2
  • Event Number
    Z-1687-2018
  • Event Initiated Date
    2018-01-02
  • 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=162522
  • 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
    Cyclosporine - Product Code MKW
  • Reason
    The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the dimension tshl, dimension loci ft4l, dimension vista tsh, advia centaur cyclosporine, and advia centaur dheas, incorrectly state the level at which biotin does not interfere.
  • Action
    Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA

Device

Device Recall ADVIA Centaur Cyclosporine
  • Model / Serial
    ADVIA Centaur¿ Cyclosporine; Cyclosporine; SMN 10335448  Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 98554025 58299030 25547030 30153031 77934031 97170031
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada, Mexico, and Thailand
  • Product Description
    ADVIA Centaur¿ Cyclosporine
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA