Events

Recall of Nova Biomedical StatStrip and StatSensor batteries

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Nova Biomedical Corp.

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
    15810
  • Event Initiated Date
    2013-12-06
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: New Zealand Medical & Scientific Ltd, 2A Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Reason
    The manufacturer advises 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., nova biomedical is recalling statstrip/statsensor batteries that do not have expiration dates printed on them that help to ensure the batteries are not used beyond their intended useful life.
  • Action
    Product to be exchanged

Device

Nova Biomedical StatStrip and StatSensor batteries
  • Model / Serial
    Model: StatStrip and StatSensor, Affected: All batteries without expiry dates
  • Manufacturer
    Nova Biomedical Corp

Manufacturer

Nova Biomedical Corp