Events

Safety Alert for CASSETTE for UROANALYSIS 10 Clinitek Novus CASSETTE for UROANALYSIS PRO 12 Clinitek Novus

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 / SIEMENS || HEALTHCARE COLOMBIA.

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-020716
  • Event Number
    INVIMA 2014RD-0002797
  • Date
    2016-07-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 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
    Siemens healthcare diagnostics has confirmed that certain lots of clinitek novus® urinalysis cassettes can report glucose as "error" for some urine samples and negative quality controls more frequently than expected. an "error" instead of a result for deorine glucose can lead to a delay in the test until a repeat or alternate test can be performed. the risk to health is insignificant.

Device

CASSETTE for UROANALYSIS 10 Clinitek Novus CASSETTE for UROANALYSIS PRO 12 Clinitek Novus
  • Model / Serial
    SMN code: 10634643, lots: K232105, K234105, K236115. || SMN Code: 10697847, lots: K233105 || SMN Code: 10634644, lots: R229105, R230105, R238115. || SMN Code: 10697848, lots: R231105
  • Product Description
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS / SIEMENS || HEALTHCARE COLOMBIA

Manufacturer

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