Events

Recall of FB Reagent, ZYM B Reagent, API Listeria and API NHFB Reagent

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomerieux Australia Pty Ltd.

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
    RC-2014-RN-00293-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00293-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    During the quality control of new lot of fb reagent, a visual defect (colour issue) was observed. the first investigation performed by the manufacturing site showed that this visual defect is due to a specific lot of raw material used for the manufacturing of this fb reagent. in addition, this lot of raw material has also been used for the manufacturing of several lots of fb reagent and zym b reagent using the same raw material than the fb reagent. as the involved lots of zym b reagent are included inside of api nh and api listeria kits, the both references are also impacted.
  • Action
    BioMeriuex is requesting their customers to discontinue use and discard any stock with visual defects. Testing using the affected lost can continue if daily QC is run using a validated ATCC strain.

Device

FB Reagent, ZYM B Reagent, API Listeria and API NHFB Reagent
  • Model / Serial
    FB Reagent, ZYM B Reagent, API Listeria and API NHFB ReagentReference Number: 70562ZYM B reagentReference Number: 70493API NHReference Number: 10400API ListeriaReference Number: 10300Multiple lot numbers affected
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd