Events

Recall of Waters Mass Spectrometers

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

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
    13966
  • Event Initiated Date
    2013-02-15
  • 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: SciMed Ltd, Unit 2, 1 Tussock Lane, Ferrymead, Christchurch 8023
  • Reason
    The ion block source heater can fail, potentially leading to inaccurate results which may not be picked up by quality control or internal standard monitoring., assays with shorter dwell times are most affected, including neonatal screening for phenylketonuria, medium chain acyl coa dehydrogenase deficiency and maple syrup urine disease.
  • Action
    Product to be modified

Device

Waters Mass Spectrometers
  • Model / Serial
    Model: 9 models, Affected: All serial numbers
  • Manufacturer
    Waters Corporation

Manufacturer

Waters Corporation