Events

Recall of Dihydrotestosterone (DHT) RIA

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    21303
  • Event Initiated Date
    2017-04-10
  • 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: Abacus ALS Limited, 55b Richard Pearse Drive, Airport Oaks, Auckland 2022
  • Reason
    The manufacturer noticed that the kmno4 reagent (#3205213) - lot 16h8 - included in the dihydrotestosterone (dht) ria kit may lead to elevated concentrations, especially for male samples. the impact of the affected kmno4 (lot 16h8) was less visible on female samples. because this reagent is used in the extraction step, elevated values were not observed on the standard curve nor on the kit controls. only extracted samples are susceptible to higher results.
  • Action
    Product to be exchanged

Device

Dihydrotestosterone (DHT) RIA
  • Model / Serial
    Model: , Affected: Cat. Number. DE5170, Lot. 164808/C
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479