Events

Recall of Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. 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-00628-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00628-1
  • 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 ltd, part of thermo fisher scientific, has determined that thermo scientific remel salmonella paratyphi a-h stained suspension (r30855101) is showing granularity, upon dispensing, which may be misinterpreted as a positive result when used according to the instructions for use (ifu).
  • Action
    Thermo Fisher Scientific is requesting users:- Inspect your stocks and remove from further use all units from the affected batch number, then complete the Facsimile Reply Form supplied with the customer letter and fax it to us so that we may arrange for a credit note to be issued. Please complete the Facsimile Reply Form even if you have no remaining stock which is subject to recall, as we require this information to reconcile this process. Any requirement for review of patient results should be determined by the laboratory director.

Device

Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. An in vitro diag...
  • Model / Serial
    Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. An in vitro diagnostic medical device (IVD)Lot Numbers: 2184561, 2308897, 2228271, 2213610 & 2258333ARTG number: 236824(Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate agglutination reagent IVDs)Possibility of Granularity Upon Dispensing
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand