Events

Recall of Abbott Clinical Chemistry Urea Nitrogen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories, 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
    60059
  • Event Risk Class
    Class 2
  • Event Number
    Z-0189-2012
  • Event Initiated Date
    2011-10-03
  • Event Date Posted
    2011-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104362
  • 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
    The reagents are being recalled due to particulate matter in some of the reagent cartridges. the particulate matter has been identified as aureobasidium fungus species.
  • Action
    The firm decided to recall and they sent a Product Recall Letter to their customers on 10/03/2011. Questions regarding the letter should be directed to Customer Service at 1-877-4ABBOTT for US customers, and customers outside of the US should contact their local area Customer Service. Customers should determine if you have any remaining inventory. Please discontinue and destroy any remaining inventory of these lots. Order alternative lots of Clinical Chemistry Urea Nitrogen. Complete and return the enclosed Customer Reply form.

Device

Abbott Clinical Chemistry Urea Nitrogen
  • Model / Serial
    Urea Nitrogen 7D75-21 (lot 97642UN11) and Urea Nitrogen 7D75-31 (lot 97668UN11)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038-4313
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA