Events

Recall of Remel Wellcolex Colour Shigella Reagent. 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-01103-1
  • 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-01103-1
  • 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 thermo fisher scientific has confirmed that specific lots of remel wellcolex colour shigella reagent may notagglutinate in the presence of positive cultures. a negative result indicates that the organisms under test do not belong to the serotypes of shigella species covered by the reagents. latex reagent 2 is used to identify common serotypes of s. dysenteriae and s. boydii. continued use of these lots may result in a failure to correctly identify s. boydii. s.Dysenteriae results are unaffected. latex reagent 1 continues to perform correctly and will identify common serotypes of s. sonnei and s. flexneri.
  • Action
    1. Inspect your stocks and remove from further use of all units from the impacted batch number, then complete and return the Facsimile Reply Form supplied with the customer letter. 2. If any recalled stock has been transferred from your laboratory to another, inform that laboratory of the recall action.

Device

Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)Product Code: R30858401Lot Numbers: 1991413, 2130764, 2110576, and 2143554ARTG Number: 236824
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand