Events

Recall of Microgenics CEDIA Tobramycin II Assay

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Microgenics 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
    15590
  • Event Initiated Date
    2013-10-29
  • 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
    In-house testing of the cedia® tobramycin ii assay (ln: 60169764) shows that the reconstituted reagents do not maintain 30 days reconstituted stability. the instability of the reconstituted reagents may cause higher recovery of samples. hence, lot number 60169764 reagents must be used within 14 days after reconstitution. reconstituted reagents beyond the 14 days should be discontinued and discarded.
  • Action
    Instructions for use to be updated

Device

Microgenics CEDIA Tobramycin II Assay

Manufacturer

Microgenics Corporation