Events

Safety Alert for Complement Control Cells, lot 34161

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

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
    2011-10-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111023.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
    Field safety notice: immucor gamma complement control cells, lot 34161 medical device supplier, uninet technology ltd, issued an urgent product recall concerning complement control cells, lot 34161. complement control cells is a blood blank quality control reagent used to confirm the reactivity of the anti-c3 component of anti-human globulin. post-release testing on the complement control cells, lot 34161, has confirmed reports of weakened reactivity and negative results when using the product. immucor gamma requests customers stop using this lot and discard any remaining inventory. according to the local supplier, the affected product has distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Complement Control Cells, lot 34161
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Immucor Gamma Complement Control Cells, lot 34161
  • Manufacturer
    Immucor Gamma

Manufacturer

Immucor Gamma