Events

Safety Alert for INNOVASTAR and RESPONS 910/920 and BIOMAJESTY

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Diasys Diagnostics Systems Gmbh.

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
    I1502-78
  • Event Number
    2012DM-0008452
  • Date
    2015-02-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 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 states that a software anomaly under certain circumstances may result in invalid patient test results, this if a multi-point calibration is performed with one of the expired calibrators but the restoratives are still within their useful life, consequently, the calibration point is not valid it will not be used for the calculation of the calibration curve, but another calibration point will be used twice instead, leading to possible errors in the results of patient sample processing and adverse events.

Device

INNOVASTAR and RESPONS 910/920 and BIOMAJESTY
  • Model / Serial
    RESPONS 910
  • Product Description
    The blood chemistry analyzers INNOVASTAR and RESPONS 910/920 and BIOMAJESTY from DIASYS® laboratory equipment with an automated platform, continuous random access controlled by their software, colorimetric techniques, ISE, nephelometry and enzymatic porinmunoassays for multiple tests for endocrinology, chemistry and immunology , both quantitative and qualitative. Processes urine, fluid, serum or plasma samples for in-vitro diagnostic tests (IVD). The reagents used with the analyzers for INNOVASTAR and RESPONS 910/920 and BIOMAJESTY of DIASYS have respective health records.
  • Manufacturer
    Diasys Diagnostics Systems Gmbh

Manufacturer

Diasys Diagnostics Systems Gmbh