Events

Recall of Dimension Enzymatic Creatinine Flex reagent cartridge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dade Behring, 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
    50075
  • Event Risk Class
    Class 2
  • Event Number
    Z-0485-2009
  • Event Date Posted
    2008-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74652
  • 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
    Creatinine enzymatic method - Product Code JFY
  • Reason
    Reagent may exhibit unflagged inaccurate patient sample results.
  • Action
    The recalling firm telephoned all customers on 9/29/08 to inform them of the problem. Customers were issued a letter dated 9/29/08 (and a response form) with instructions. Customers were instructed to complete the response form and fax (302-631-7242) it to Siemens Healthcare Diagnostics. For questions or additional information, contact the Siemens Technical Solutions Center at 800-441-9250.

Device

Dimension Enzymatic Creatinine Flex reagent cartridge
  • Model / Serial
    Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062, GA9043, GD9069, and GD9087.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. || The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
  • Manufacturer
    Dade Behring, Inc.

Manufacturer

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