Safety Alert for Alanine Aminotransferase (ALT) Glucose-STAT

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BECKMAN COULTER INC || Importer:ROCHEM BIOCARE 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
    IRD-020616
  • Event Number
    INVIMA 2006RD-0000208
  • Date
    2016-06-08
  • Event Country
  • Event Source
    INVIMA
  • 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
    Low results in patients treated with sulfasalazine and sulfapyridine. the interference observed at concentrations of 300 mg / l of sulfasalazine showed a negative bias of up to 35% for the low control of alt and up to 29% for the high control of alt. the interference observed with a concentration of 300 mg / l of sulfasalazine showed a 10% sga up to 25% (or 1.3 mmol / l) for the control of the glucose - stat low and up to 13% (or 1.6 mmol / l ) for the control of glucose - stat. at concentrations of 300 mg / l of sulfapyridine, a positive bias of up to 21% (or 1.1 mmol / l) was demonstrated for glucose control- low stat and up to 9% or (1.1 mmol / l) for glucose control - high stat.

Device

  • Model / Serial
    ALANIN AMINOTRANSFERASE (ALT), reference OSR6X07, all batches. GLUCOSE-STAT, reference OSR6X40, all batches.
  • Product Description
    QUANTITATIVE DETERMINATION OF RELATED ANALYTS, IN SAMPLES FROM THE HUMAN MOTION.
  • Manufacturer

Manufacturer