Events

Safety Alert for DIMENSION Hemoglobin A1c. (HB1c Flex)

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.

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-020915
  • Event Number
    INVIMA 2012RD-0002192
  • Date
    2015-09-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=172
  • 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 actual dimension® hb1c flex® cartridge batches listed in table 1 may produce an "e" coefficient value in the calibration that is above the guidelines published in the kit hemoglobin a1 (hb1c) supplement (5 to 8, conventional units [8 to 13, si units]).

Device

DIMENSION Hemoglobin A1c. (HB1c Flex)
  • Model / Serial
  • Product Description
    Quantitative determination of hemoglobin HBA 1C in the blood as a control of diabetes
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA