Events

Safety Alert for Film Array Blood Culture Identification BCID Panel

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S..

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-030516
  • Event Number
    INVIMA 2014RD-0003003
  • Date
    2016-05-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=143
  • 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
    Labeling problem with a suitable electronic code key, generating the download of an obsolete version of the instructions of the product by the customers. the obsolete use instructions refer to the old syringe loading system, in contrast to the current system, which is based on an injectable method of the vial. the most significant difference between the two sets of instructions is the volume of the sample needed to perform the test. the syringe system requires 100 ul of the sample, while the new system requires 200 ul demonstrates. biofire has shown that there are no differences between the two sample volumes, therefore, any risk to patients and the risk of erroneous results are very low.

Device

Film Array Blood Culture Identification BCID Panel
  • Model / Serial
    Code: RFIT-ASY-0126, lots 440415, 442715, 447415, 447615, || 448315, 454115, 458915, 459615, 462615, 470515, 400216, || 400716, 403016, 403616, 405416, 407016, 407416, 410216, || 412516. || Code: RFIT-ASY-0127, lots: 438115, 449515, 442815, 459715, || 463115, 468015, 410016
  • Product Description
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S.

Manufacturer

BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S.