Events

Recall of Device Recall Hypoguard Advance

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hypoguard USA, 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
    27760
  • Event Risk Class
    Class 2
  • Event Number
    Z-0276-04
  • Event Initiated Date
    2003-11-26
  • Event Date Posted
    2003-12-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30532
  • 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 Oxidase, Glucose - Product Code CGA
  • Reason
    When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
  • Action
    The consignees were sent letters dated 11/26/03 which requested that the product be returned.

Device

Device Recall Hypoguard Advance
  • Model / Serial
    Lots 01143A, 02263A, 03103A, 10222A, 12212A, 12312A, 03183A, 04293A, and 05273A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to consignees located nationwide in the United States.
  • Product Description
    Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips
  • Manufacturer
    Hypoguard USA, Inc.

Manufacturer

Hypoguard USA, Inc.
  • Manufacturer Address
    Hypoguard USA, Inc., 5182 W 76th St, Edina MN 55439-2900
  • Source
    USFDA