Events

Recall of ONETOUCH VERIO IQ BLOOD GLUCOSE METER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON 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
    120566
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The onetouch verio iq will not work as expected at extremely high blood glucose levels of 56.8 mmol/l (1023 mg/dl) or above. the onetouch verio iq will not display a result and will not write to memory. the meter will countdown then turn off instead of displaying a result.

Device

ONETOUCH VERIO IQ BLOOD GLUCOSE METER
  • Model / Serial
    Model Catalog: 022-282 (WARRANTY) (Lot serial: all lots); Model Catalog: 011-838 (Lot serial: all lots); Model Catalog: 022-276 (SYSTEM KIT) (Lot serial: all lots); Model Catalog: 022-277 (STARTER KIT) (Lot serial: all lots)
  • Product Description
    OneTouch Verio IQ Blood Glucose Meter
  • Manufacturer
    LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.