Events

Recall of Device Recall Dimension IBCT Flex Reagent Cartridge

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
    54460
  • Event Risk Class
    Class 3
  • Event Number
    Z-2385-2010
  • Event Initiated Date
    2009-12-16
  • Event Date Posted
    2010-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88527
  • 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
    Ferrozine (colorimetric) iron binding capacity - Product Code JMO
  • Reason
    Test produces falsely elevated ibct results and abnormal reaction test report messages on heparinized plasma samples.
  • Action
    Siemens issued an "Urgent Field Safety Notice" letter dated December 2009 to users identifying the issue and affected product. Customers were instructed not to use heparinized plasma samples for IBCT testing. IBCT Instructions for Use (IFU) has been updated to reflect that heparinized plasma is no longer an acceptable sample type. Beginning with lot ED0341, the new IFU will be packaged in the carton with the IBCT Flex¿ reagent cartridges. Consignees were requested to forward the notification letter to anyone to whom the product was distributed. The Siemens Technical Solutions Center can be contacted at 800-441-9250.

Device

Device Recall Dimension IBCT Flex Reagent Cartridge
  • Model / Serial
    Catalog number df84
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (all states) and the countries of Canada, Switzerland, New Zealand, Australia, Japan, and South Korea.
  • Product Description
    Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA