Safety Alert for AMYLASE

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 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
  • Event Number
    INVIMA 2006 RD-0000271
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Increase in the frequency of amylase absorbance error messages. siemens healthcare diagnostics has confirmed that the amylase lotes reagent kit 304821 and 304816 for use on the advia® 1200, 1650, 1800 and 2400chemistry systems platforms showed an increase in the absorbance error message rate (u or u followed by u).