Events

Recall of Device Recall Siemens Medical Solutions Diagnostics

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

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
    46346
  • Event Risk Class
    Class 2
  • Event Number
    Z-1119-2008
  • Event Initiated Date
    2008-01-12
  • Event Date Posted
    2008-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67216
  • 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
    in vitro diagnostic Hepatitis A - Product Code LOL
  • Reason
    Incorrect results: false reactive specimens on the advia centaur hav igm assay.
  • Action
    Siemens issued a Urgent Field Safety Notiifcation (078D0709-01) to all Siemens Diagnostics Branches on 1/12/08 for communication to their customers. This Customer Bulletin/Urgent Field Safety Notification advises the customer of the problem and the actions to be taken to mitigate risk. A Confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action.

Device

Device Recall Siemens Medical Solutions Diagnostics
  • Model / Serial
    All lots
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
  • Product Description
    ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.
  • Manufacturer
    Siemens Medical Solutions Diagnostics

Manufacturer

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