Events

Safety Alert for ORTHO VISION ANALYZER IDMTS

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Tecan Schweiz Ag || Ortho Clinical Diagnostics.

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
    A1604-141
  • Event Number
    2015DM-0012864
  • Date
    2016-04-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=148
  • 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 has detected a possible security problem where the software incorrectly interprets for one day the built-in expiration dates of 2016-02-29 and later that are on the labels with code debarras (barcodes) for ortho reagent products, the miscalculation of the date of the expiration of the reagent existed since february 29 and will continue until the end of 2016, leading to potential delays in the processing of the samples.

Device

ORTHO VISION ANALYZER IDMTS
  • Model / Serial
    6904577, specific serials with software version 1.2.10 and earlier.
  • Product Description
    ORTHO VISION ANALYZER is a device designed to automate in vitro immunohematological analysis of human blood using the cassette technology ofORTHO BIOVUE SYSTEM. ORTHO VISION ANALYZERautomatizes test processing functions, such as liquid pipetting, reagent handling, incubation, centrifugation, classification and interpretation of reactions and requirements for data management through cassettes and digital image processing.ORTHO VISION ANALYZER It can be used as an independent team or connected to the customer's computer system (LIS).
  • Manufacturer
    Tecan Schweiz Ag || Ortho Clinical Diagnostics

Manufacturer

Tecan Schweiz Ag || Ortho Clinical Diagnostics
  • Source
    NIDFSINVIMA