Events

Recall of Device Recall Urea Nitrogen (UN) Reagent Kit

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
    79932
  • Event Risk Class
    Class 2
  • Event Number
    Z-2062-2018
  • Event Initiated Date
    2018-03-27
  • 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=163963
  • 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
    Urease and glutamic dehydrogenase, urea nitrogen - Product Code CDQ
  • Reason
    Urea nitrogen reagent kit demonstrated an increased incidence of calibration failures. results cannot be generated by the system when calibration fails.
  • Action
    Date recall was initiated: 03-27-18 Customer communication was sent on 04-03-18 Urgent Medical Device Recall (CHC18-04.A.US) was distributed to all customers in the United States and an Urgent Field Safety Notice (CHC18-04.A.OUS) was distributed to all customers outside the United States who have received ADVIA Chemistry Urea Nitrogen reagent kit lots 408143 and 418290 (Lot 418290 was not sold in the US). These letters instruct the customers to discontinue use of reagent kit lots 408143 and 418290 and to contact their Customer Care Center for replacements kits. In the US the method of distribution is Fed Ex and outside the US the distribution is determined at the country level.

Device

Device Recall Urea Nitrogen (UN) Reagent Kit
  • Model / Serial
    Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide
  • Product Description
    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
  • 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