Events

Recall of Multiple brand names including: Precision Xtra

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Diabetes Care, 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
    39371
  • Event Risk Class
    Class 2
  • Event Number
    Z-0112-2008
  • Event Initiated Date
    2007-08-02
  • Event Date Posted
    2008-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55300
  • 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
    blood glucose meter - Product Code NBW
  • Reason
    Damage could lead to no display. meters manufactured after january 31, 2007 could exhibit meter display damage if dropped on a hard surface. these meters could exhibit unreadable lot number fields and date/time fields, in addition to complete blanking of the numerical reading portion of the display.
  • Action
    Abbott sent Urgent Medical Device Correction letters, dated 31Aug07, to registered users/customers via FedEx or mail. The letter instructs users to verify that their display is correct, and if not, to discontinue use and call Abbott Customer Care at 1-877-844-4404 for a new meter. Warranty kits will have fliers added to them to alert users. Email and telephone contacts may be made as needed. U.S. consignees and registered users will be contacted by letter, telephone call or visit starting 23Aug07. Worldwide, customer lists will be created and communications tracked according to local requirements. Abbott issued a Press Release August 31, 2007 also.

Device

Multiple brand names including: Precision Xtra
  • Model / Serial
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Canada, Mexico, Australia, Malaysia, Philippines, Germany, New Zealand, China, India, Singapore, Hong Kong, Taiwan, Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Peru, Puerto Rico, Uruguay, Venezuela, and Japan.
  • Product Description
    Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Kroger meter, Omron HEA-214 meter, Optium Xido meter, Boots meter.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

Abbott Diabetes Care, Inc.
  • Manufacturer Address
    Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA