Events

Recall of AQT90 FLEX

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RADIOMETER AMERICA 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
    63300
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-23
  • 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
    Radiometer has recently become aware that the internal temperature in the aqt90 flex analyzer under worst case conditions may slightly exceed acceptable storage conditions for aqt90 flex on-board test cartridges. to ensure that the temperature does not exceed maximum limit the environmental specifications for the ambient temperature for the aqt90 flex analyzer has been adjusted to 30c/86f (down from 32c/89.6f).

Device

AQT90 FLEX
  • Model / Serial
    Model Catalog: 393-838 (Lot serial: N/A)
  • Product Description
    AQT90 FLEX
  • Manufacturer
    RADIOMETER AMERICA INC.

Manufacturer

RADIOMETER AMERICA INC.