Events

Recall of EasyCheck Pregnancy Test Cassette

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Hangzhou Clongene Biotech Co 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
    18808
  • Event Initiated Date
    2015-07-03
  • 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: Phoenix MedCare Limited, 25K Garnet Road, Westmere, Auckland 1022
  • Reason
    Individual test pouches have a misprint in the results illustration under heading "invalid" showing an"invalid" result to be equal to a "negative" result., a negative result may be interpreted as an invalid result if the ifu not consulted., , , our product is supplied in boxes of 40 tests, and an ifu is included with each box. the pouch printing was a feature we have introduced on the new funded product, as an improvement to the previous tender holder (blank pouches).
  • Action
    Product to be modified

Device

EasyCheck Pregnancy Test Cassette

Manufacturer

Hangzhou Clongene Biotech Co Ltd