Events

Recall of qUAntify Control

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
    23105
  • Event Initiated Date
    2018-06-08
  • 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
    The manufacturer has observed that the values for blood and ketones may gradually decrease and values for ph may gradually increase over the shelf life of certain product lots. information has been added to the storage and stability section in the package insert.
  • Action
    Instructions for use to be updated

Device

qUAntify Control
  • Model / Serial
    Model: , Affected: qUAntify Control - Lots 78770, 78780, qUAntify Plus Control - Lots 80510, 80520, 80530, 80540, 80550, 80560, qUAntify Plus Control - Lots 79610, 79620, 79630, 79640, 79650, 79660
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc