Events

Safety Alert for Remel Vibrio cholerae Inaba agglutinating serum

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
    2013-06-28
  • Event Date Posted
    2013-06-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130628.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 scientific remel vibrio cholerae inaba agglutinating serum medical device manufacturer, thermo fisher scientific, has issued a field safety notice concerning remel vibrio cholerae inaba agglutinating serum (model no.: zm06/r30165101 and lot no.: 1155581). according to the manufacturer, an internal technical investigation has confirmed that the performance of vibrio cholerae inaba agglutinating serum lot: 1032772 sold separately as r30165101 lot: 1155581 has deteriorated, and is no longer agglutinating with positive cultures in the slide and tube agglutination test. the manufacturer advises customers who have used the affected lot of vibrio cholerae inaba agglutinating serum to review results reported and consider retesting and/or seek appropriate expert advice as a false negative result may have been obtained. furthermore, the manufacturer requests users to destroy any remaining inventory of the affected vibrio cholerae inaba agglutinating serum and contact customer services or local distributor to request replacement product. according to the manufacturer, the affected products were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 june 2013.

Device

Remel Vibrio cholerae Inaba agglutinating serum
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Thermo Fisher Scientific Remel Vibrio cholerae Inaba agglutinating serum
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific