Events

Recall of Bio-Rad Liquichek Specialty Immunoassay Controls (Level 1 to 4)

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
    19737
  • Event Initiated Date
    2016-02-05
  • 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
    Manufacturer has observed that intact pth may not meet the thawed unopened and thawed open vial stability claims as printed in the package inserts., (5 customers reported intact pth failing to meet the 23 days thawed open vial stability claim at 2 to 8 deg c.0.
  • Action
    Instructions for use to be updated

Device

Bio-Rad Liquichek Specialty Immunoassay Controls (Level 1 to 4)
  • Model / Serial
    Model: 359 359X 364 365 and 366, Affected: Master Lot Nos: 57430 57440 57450 57460 57470 57480 and 57490
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc