Events

Safety Alert for ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ABBOTT GMBH & CO. KG CON DOMICILIO EN || ALEMANIA. || Imported by: ABBOTT LABORATORIES DE COLOMBIA 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
    RRD-031216
  • Event Number
    INVIMA 2011RD-0002106
  • Date
    2016-12-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=110
  • 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
    Abbott has identified a problem of specific stabilities of the reagent lots 10533up00 and 10535up00. as the reagent approaches the expiration date, the values in relative units of light (url) of the calibration curve decrease, causing the results of patients calculated with this diminished curve to rise excessively, resulting in false patient results. the controls may not reflect the instability of the reactive, since the recalibration can make the values of the controls are within the acceptable ranges.

Device

ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT

Manufacturer

ABBOTT GMBH & CO. KG CON DOMICILIO EN || ALEMANIA. || Imported by: ABBOTT LABORATORIES ...
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA