Events

Safety Alert for DIMENSION ENZYME II CALIBRATOR (ENZ II CAL)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by SIEMENS HEALTHCARE DIAGNOSTICS INC || Importer: SIEMENS 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-090516
  • Event Number
    INVIMA 2015RD-0003233
  • Date
    2016-05-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=139
  • 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
    Change in calibration values when using these batches in the alti (alanine-transferase) test. internal studies showed a displacement of 10% of said values in patient samples and quality controls, in comparison with the results obtained using other lots. however, it is expected that the reallocation of these values will produce a displacement of the values by 8%. the clinical impact is based on the reprocesses that may cause this change.

Device

DIMENSION ENZYME II CALIBRATOR (ENZ II CAL)
  • Model / Serial
    Catalog: DC143, SMN Code: 10476170, Lots: 4MD047, || 5CD052, 5FD017, 5GD050, 5HD010, 5JD069, 5LD051, 6AD054
  • Product Description
    DETERMINATION OF DIFFERENT ANALYTS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION.
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC || Importer: SIEMENS S.A

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC || Importer: SIEMENS S.A
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA