Events

Recall of Alere Actim Partus

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medix Biochemica Oy Ab.

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
    17880
  • Event Initiated Date
    2014-12-17
  • 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: Alere Ltd, C/- Bell Gully, Level 22, Vero Centre, 48 Shortland Street, AUCKLAND 1010
  • Reason
    Certain batches of actim partus dipsticks have shown increased non-specific binding during late stages of the 24 month shelf-life of the product. this issue increases the risk of false-positives results. the issue does not affect negative results which are still valid.
  • Action
    Instructions for use to be updated

Device

Alere Actim Partus
  • Model / Serial
    Model: Catalogue Numbers: 31930ETAL, 31931ETAL, 31931ETAC, Affected: Multiple lot numbers
  • Manufacturer
    Medix Biochemica Oy Ab

Manufacturer

Medix Biochemica Oy Ab