Events

Recall of Device Recall Assure 3 Blood Glucose Test Strips

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
    45966
  • Event Risk Class
    Class 2
  • Event Number
    Z-0699-2008
  • Event Initiated Date
    2007-11-16
  • Event Date Posted
    2008-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66593
  • 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 Test Strips - Product Code CGA
  • Reason
    Mislabeling: incorrect control range-the level 1 control solution range printed on the 50-count test strip bottles is incorrect. the range printed on the bottle is 62-54 when it should be 62-94.
  • Action
    On Friday, November 14, 2007 the recalling firm notified their distributors via telephone and email to inform them of the device defect and replaced all devices still in inventory. The distributors were also instructed to inform all of their customers of the issue and offer replacement product. Additionally, replacement will be offered to any end user that calls customer service about the issue. To reach ARKRAY use 1-800-818-8877 extension 3121 for replacement product.

Device

Device Recall Assure 3 Blood Glucose Test Strips
  • Model / Serial
    Lot Number: AS607L
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide including the states of CA, FL, GA, IL, IN, MA, MI, MS, NC, NJ, OH, PA, and TX
  • Product Description
    Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan.
  • 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