Events

Safety Alert for TRUCAL U, TRULAB N, TRULAB P, TRULAB PROTEINA

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 || Importer: ANALISIS TECNICOS LTDA.

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
    IRD-040316
  • Event Number
    INVIMA 2007RD-0000327 ; INVIMA 2011RD-0001905
  • Date
    2016-03-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=152
  • 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
    A modification of the white values in the document attached to the report is notified, for which reason the parent company requests to replace the old calibration values and update the new information of the controls in the software of the analyzers.

Device

TRUCAL U, TRULAB N, TRULAB P, TRULAB PROTEINA
  • Model / Serial
    TruCal U, reference: 5 9100; lot: 20695 || TruLab N, reference: 5 9000; lot: 20270 || TruLab P, reference: 5 9050; lot: 20271 || TruLab Protein Level 1, reference: 5 9500; lots: 19360 & 20381 || TruLab Protein Level 2, reference: 5 9510; lots: 19361 & 20382 || TruLab Urine Level 1, reference: 5 9170; lots: 21056 & 20541 || TruLab Urine Level 2, reference: 5 9180; lots: 21057 & 20542 || TruLab Urine Level 1 & 2, reference: 5 9175; lots 21056/21057 & || 20541/20542
  • Product Description
    THESE 15 PRODUCTS ARE USED TO CARRY OUT SANGUINEA CHEMISTRY TESTS
  • Manufacturer
    DIASYS DIAGNOSTICS SYSTEMS || Importer: ANALISIS TECNICOS LTDA

Manufacturer

DIASYS DIAGNOSTICS SYSTEMS || Importer: ANALISIS TECNICOS LTDA