Events

Recall of Advance Microdraw Blood Glucose Monitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ARKRAY 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
    45483
  • Event Risk Class
    Class 3
  • Event Number
    Z-0458-2008
  • Event Initiated Date
    2007-10-18
  • Event Date Posted
    2007-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65563
  • 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 Monitoring System - Product Code CGA
  • Reason
    Mis-labeled/coded strips : meter kits from this lot contain mislabeled 10-count test strip vials. the code number printed on the advance micro-draw 10-count test strip bottle is incorrect. the code number on the vial is 867 when it should be 687. the 687-labeled code chip contains the correct calibration information for the "867" test strips, so the meter will function properly and give accurat.
  • Action
    Distributors were sent a letter on 10/18/07 asking that product be quarantined. On 10/26/07, an Urgent Voluntary Medical Device Recall letter was sent asking that they return affected product and contact their customers to the retail level.

Device

Advance Microdraw Blood Glucose Monitoring System
  • Model / Serial
    Part Number 411100, Lot Number: 09177A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: USA including states of CA, MI, MO, MS, NE, OH and TX.
  • Product Description
    Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Codeing chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide)
  • Manufacturer
    ARKRAY USA INC.

Manufacturer

ARKRAY USA INC.
  • Manufacturer Address
    ARKRAY USA INC., 5182 W 76th St, Minneapolis MN 55439-2900
  • Manufacturer Parent Company (2017)
    Arkray Global Business Inc.
  • Source
    USFDA