Events

Recall of Trinity Biotech Lab 21 Malaria EIA 96T

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

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
    17933
  • Event Initiated Date
    2014-12-24
  • 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
    Trinity biotech has received complaints of the positive control giving low, out of range results. during the complaint investigation it was noted a drop in absorbance value of the positive control may occur. this could result in an invalid test run.
  • Action
    Product to be destroyed

Device

Trinity Biotech Lab 21 Malaria EIA 96T
  • Model / Serial
    Model: Catalogue Number: Z60127, Affected: Lot: 104283
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech