Events

Recall of Bio-Rad Urinary Catecholamines by HPLC Reagent Kit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Bio-Rad Laboratories Inc.

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
    14031
  • Event Initiated Date
    2012-12-28
  • 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: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Reason
    In some urine samples the concentration of adrenaline/epinephrine may decrease when analysis time is >8 hours., this decrease in concentration occurs only, if samples were subsequently adjusted to ph 5 to ph 7 as described in the instruction for use for very acidic samples or samples with low 24-volumes., there is a risk of false negative result being reported when samples experience these conditions.
  • Action
    Instructions for use to be updated

Device

Bio-Rad Urinary Catecholamines by HPLC Reagent Kit

Manufacturer

Bio-Rad Laboratories Inc