Events

Safety Alert for LUMINEX Fluoroanalyzer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Luminex Corporation || Immucor Transplant Diagnostics, Inc.

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
  • Event ID
    R1704-142
  • Event Number
    2010DM-0006525
  • Date
    2017-04-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=93
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer informs that the client has reported problems since the month of the connectivity between the xponent 4.2 software and the medical device, which have been presented in a randomized manner, these problems are manifested with the error message "error getting device property" and subsequent blocking of the software, being necessary to restart the pc and analyzer to solve the inconvenience, leading to potentially delays in the processing of the samples and subsequent obtaining results.

Device

LUMINEX Fluoroanalyzer
  • Model / Serial
  • Product Description
    The LUMINEX 200 system is designed for a wide range of laboratory test applications that measure biomolecular reactions on the surface of XMAP microspheres. This system is designed for the use of in-vitro diagnostics. The LUMINEX200 system is classified according to FDA 21 CFR 1040.10 and 1040.11 as a class II laser product consisting of a class I laser product (LUMINEX 200 analyzer) and a class II laser product (bar code reader).
  • Manufacturer
    Luminex Corporation || Immucor Transplant Diagnostics, Inc

Manufacturer

Luminex Corporation || Immucor Transplant Diagnostics, Inc
  • Source
    NIDFSINVIMA