Events

Recall of Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2mL. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Thermo Fisher Scientific Australia & New Zealand.

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-2018-RN-00201-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00201-1
  • 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
    An internal technical investigation by remel europe, part of thermo fisher scientific, has confirmed that remel neisseria meningitidis poly a-d (r30166601) and neisseria meningitidis group d (r30167001) may fail to agglutinate within the specified minimum reaction time when tested with group d neisseria meningitidis bacteria. continued use of these lots may result in a failure to correctly identify isolates as group d neisseria meningitidis bacteria. the product thermo scientific remel neisseria meningitidis poly a-d (r30166601) continues to correctly identify neisseria meningitidis groups a, b and c. no other batches or pack sizes of this product are affected by this recall.
  • Action
    ThermoFisher is advising users to inspect stock and remove all units of the affected batches from further use. Users should complete the Facsimile Reply Form provided with the Customer Letter to arrange for a credit note to be issued.

Device

Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2m...
  • Model / Serial
    Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2mL. An in vitro diagnostic medical device (IVD)Catalogue Numbers: R30166601, R30167001Lot Numbers: 2239498, 2177820, 2239861, 1773410 & 1739963. ARTG Number: 236824(Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate agglutination reagent IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand