Events

Recall of Valproic Acid 6415 Antibiotic TDS MUlti Calibrator

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Beckman Coulter 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
    21515
  • Event Initiated Date
    2017-06-16
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Reason
    Valproic acid (osr6415) and tdm multicalibrator (odc6413) are missing required hazard labelling as per ghs regulation. products are incorrectly labeled as non-hazardous instead of hazardous. this change is driven by a clarification of ingredients and concentrations with the manufacturer.
  • Action
    Manufacturer to issue advice regarding use

Device

Valproic Acid 6415 Antibiotic TDS MUlti Calibrator
  • Model / Serial
    Model: , Affected: Valproic Acid OSR6415 and Antibiotic TDM Multi-Calibrator ODC6413 All Lots
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc