Events

Recall of Streptex Rapid Latex Agglutination Test. 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-2017-RN-01059-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01059-1
  • 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 themo fisher has confirmed that extraction enzyme lots 1960420 and1960621 (contained in the product lots 1959920, 1987862 and 2106328) may provide atypical performance when used with streptex g latex reagent. false positive results may be seen within the one minute reaction time detailed in the instruction for use. continued use of these lots of extraction enzyme with g latex reagent (only) may result in incorrect results reporting.
  • Action
    Users are to inspect stocks and remove from further use all units from the affected batch numbers. Complete the Facsimile Reply Form supplied with the customer letter and fax it to the sponsor for a credit note will be issued. Requirement for a review of patient results should be at the discretion of the laboratory director.

Device

Streptex Rapid Latex Agglutination Test. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Streptex Rapid Latex Agglutination Test. An in vitro diagnostic medical device (IVD)Product Number: R30950501Lot Numbers: 1959920, 1987862 and 2106328ARTG Number: 235676
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand