Events

Recall of Device Recall Dimension Iron 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
    75256
  • Event Risk Class
    Class 3
  • Event Number
    Z-0402-2017
  • Event Initiated Date
    2016-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149844
  • 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
    Photometric method, iron (non-heme) - Product Code JIY
  • Reason
    Siemens healthcare diagnostics has become aware of deferoxamine interference with dimension and dimension vista iron assays at a different concentration than listed in the instructions for use (ifu).
  • Action
    Siemens mailed an Urgent Medical Device Correction letter to all customers who received the Dimension and Dimension Vista IRON Flex reagent with an update to the Limitation of Procedure section for the Dimension and Dimension Visa IRON assays Instructions For Use (IFU) to indicate that: patients treated with metal-binding drugs (e.g. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay. Customers were told that the information provided in the letter, related to deferoxamine, supersedes the information related to deferoxamine int he current IRON IFU's for Dimension and Dimension Vista products until the IFU's are updated.

Device

Device Recall Dimension Iron Flex reagent cartridge

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA