Events

Recall of Device Recall Ascensia Contour Diabetes Care System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bayer Healthcare LLC.

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
    38118
  • Event Risk Class
    Class 1
  • Event Number
    Z-1001-2007
  • Event Initiated Date
    2007-06-06
  • Event Date Posted
    2007-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52985
  • 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 Monitoring System - Product Code LFR
  • Reason
    Incorrect unit of measure displayed : the meters report results in the wrong unit of measurement for canadian users.
  • Action
    The firm began calling Canadian customers on or about 6/06/07 to inform them of the problem, to tell them that a meter with the correct measurement units will be sent to them, and to request that they return the meter currently in their possession.

Device

Device Recall Ascensia Contour Diabetes Care System
  • Model / Serial
    NO USA Units Affected: Serial numbers 1475139, 1688643, 1841620, 1852071, 2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037 and 2319010.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada.
  • Product Description
    Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.
  • Manufacturer
    Bayer Healthcare LLC

Manufacturer

Bayer Healthcare LLC
  • Manufacturer Address
    Bayer Healthcare LLC, 430 S Beiger Street, Mishawaka IN 46544-3207
  • Source
    USFDA