Events

Recall of Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IVD)(Point of Care System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Australasian Medical & Scientific Ltd.

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
    RC-2013-RN-01322-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01322-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    This recall action is to alert users that lithium batteries utilized beyond their intended useful life may swell and/or crack the external case posing a potential safety hazard. in some cases, the swelling may cause the battery door on the meter to incorrectly seat rendering the meter inoperable.
  • Action
    AMSL is advising users that all batteries without an expiration date label will be replaced. AMSL recommends a battery inspection program is implemented to identify and remove batteries from point of use that do not have expiration dates on the battery label.

Device

Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IV...
  • Model / Serial
    Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IVD)(Point of Care System)ARTG Number: 197482
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd