Events

Safety Alert for BRAHMS Neopterin EIA

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
    2015-10-22
  • Event Date Posted
    2015-10-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151022b.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 brahms neopterin eia medical device manufacturer, thermo fisher scientific, has issued a field safety notice regarding the brahms neopterin eia. the details of the affected device are shown below: kit reference number: 99.1 lot number (expiry date): 703449 (16 october 2015) and 703450 (8 january 2016) the manufacturer informs that for the brahms neopterin eia lot 703449 and lot 703450 the“quality control report”, which is included in the kit, contains an incorrect range for the quality control k2. this might lead to validating a run, which in fact was invalid. the manufacturer advises affected users to take the following actions:- stop using the incorrect quality control range for k2 contained in brahms neopterin eia, lot 703449 and lot 703450 use the correct quality control range for k2 contained in brahms neopterin eia, lot 703449 and lot 703450 provided by the manufacturer. re-evaluate all runs, which showed a value for quality control k2 between 44.4 nmol/l and 60.4 nmol/l. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 october 2015.

Device

BRAHMS Neopterin EIA
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Thermo Fisher Scientific BRAHMS Neopterin EIA
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific