Events

Recall of Device Recall Precision Link Software

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
    37385
  • Event Risk Class
    Class 2
  • Event Number
    Z-0709-2007
  • Event Initiated Date
    2006-12-18
  • Event Date Posted
    2007-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50457
  • 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
    Glucose test system - Product Code NBW
  • Reason
    If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the precision link software.
  • Action
    Firm initiated its recall on 12/21/2006. The firm provided customer letters with additional information (eg. flyer or insert) to customers that they had addresses for via fedex. In addition, the product notification was posted on the firm's internet website. Further, a flyer is to be included as a supplement to the user manual.

Device

Device Recall Precision Link Software
  • Model / Serial
    Part Numbers: 99040-01,99063-02.99514-01,97444-04, 97444-05,97445-05,97570-04,  98891-04,98929-05,98931-04, 98889-06, 98890-05, 98891-05,  98929-06,98931-05,99063-04,  99516-03, 80378-01,80379-01,80380-01,  80381-01, 80382-01,80383-01,  80392-01, 70519-01, 80392-02
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA as well as abroad to Argentina, Aruba, Australia, Austria, Bahamas, Belgium, Canada, Colombia, Croatia, Curacao, Czech/Slovak Republics, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Japan, Korea, Latvia, Lithuania/Estonia (Baltics), Mexico, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Portugal, Saudi Arabia, Serbia, Bulgaria/Macedonia, Singapore, Slovenia, South Africa, Spain, St. Maarten, Sweden, Switzerland, Turkey, UK and Venezuela.
  • Product Description
    Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Serial Number(s): ALL;
  • 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