Events

Recall of Trinity Biotech Captia Cytomegalovirus (CMV) IgG

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
    15374
  • Event Initiated Date
    2013-09-16
  • 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: Banksia Scientific Pty Ltd (NZ), 12 Brigade Street, Airport Oaks, Auckland
  • Reason
    Upon review of the qa release testing, the range that was calculated at the time of kit release was calculated per standard operating procedures and supports the positive control range that was assigned upon release of 2.2-4.1., however, upon investigation of history (as a positive control in several kit lots) and additional testing it has been re-evaluated and determined that this range requires an adjustment to 2.2-4.6., if you have used this kit lot to test and report patient results, and the positive control was within the assigned range (2.2-4.1), then the reported patient results were valid.
  • Action
    Instructions for use to be updated

Device

Trinity Biotech Captia Cytomegalovirus (CMV) IgG
  • Model / Serial
    Model: Product Code: 2325200, Affected: Lot Number: 557
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech