Events

Safety Alert for Tina-quant hBa1c Gen 2

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ROCHE DIAGNOSTICS MANNHEIM GMBH || Imported by: PRODUCTOS ROCHE S.A..

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-011016
  • Event Number
    INVIMA 2016RD-0003782
  • Date
    2016-10-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=119
  • 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 health agency notifies, that roche diagnosticsmannheim gmbh "(...) reports that it has identified a possible high recovery in the qc materials and patient samples, in all batches of the reagent related in the upper part of the report, after being appropriately stored below the 0 ° c ", likewise manifests that" (...) the internal investigation carried out by our housekeeper defined that the definitive cause is unknown. investigations assume that unintentional storage at low temperatures even below 0 ° c in the client, or during transport, could cause the formation of precipitates in the antibody reagent, which leads to falsely elevated results ".

Device

Tina-quant hBa1c Gen 2

Manufacturer

ROCHE DIAGNOSTICS MANNHEIM GMBH || Imported by: PRODUCTOS ROCHE S.A.