Events

Recall of Biomerieux ZYM B Reagent

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

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
    15663
  • Event Initiated Date
    2013-11-14
  • 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: BioMerieux New Zealand Ltd, Suite 4, The Business Connection Office, 2 Kalmia Street, Auckland 1544
  • Reason
    The manufacturer has identified a vusual defect and activity issue of the zym b reagent which is used as an additional test for revealing the results of some miniaturized tests included in api nh and api listeria. a risk analysis has been done to assess the impact of the zym b activity issue on the test results. the investigations concluded that it could lead to misidentificiation of some species with api strep, api nh, api listeria and api coryne.
  • Action
    Product to be destroyed

Device

Biomerieux ZYM B Reagent
  • Model / Serial
    Model: 70493, Affected: Multiple
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA