Events

Safety Alert for Remel Streptex Group D Latex Reagent

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Thermo Fisher Scientific.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-04-09
  • Event Date Posted
    2013-04-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130409a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: thermo fisher remelstreptex group d latex reagent medical device manufacturer, thermo fisher scientific issued a medical device safety alert concerning remelstreptex group d latex reagent with model number r30950901 and lot number 1215767. according to the manufacturer,an internal technical investigation has confirmed that streptex group d latex lot: 1215767 sold separately as r30950901 lot: 1215642 and contained within the kits detailed below, may give weak or false negative test results: streptex latex agglutination test (200 tests) r30164701 lot: 1215568 streptex latex agglutination test (50 tests) r30950501 lot: 1215567 streptex latex agglutination test (50 tests) r30950901 lot: 1215642 the positive control reagent continues to react satisfactorily with the latex and will not indicate that the reagent is weak. continued use of these kits may result in false negative test results with some cultures. the manufacturer advises the affected customers to: destroy any remaining stock; contact customer services or local oxoid supplier who will issue a replacement; review results reported using this lot; and consider retesting and/or seek appropriate expert advice. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 april 2013.

Device

Remel Streptex Group D Latex Reagent
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Thermo Fisher RemelStreptex Group D Latex Reagent
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific