Recall of ADVIA Chemistry Total Protein_2 reagent (Urine) (UPRO_2). An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Due to the formation of a precipitate in affected lots of the advia chemistry upro_2 reagent indicator dye, an increase in failed calibrations and quality control (qc) failures has been observed. these shifts will lead to quality control failures resulting in no patient result being reported with the affected kits.
  • Action
    Customers are advised to discontinue use and discard all affected lots. This action has been closed-out on 10/02/2016.


  • Model / Serial
    ADVIA Chemistry Total Protein_2 reagent (Urine) (UPRO_2). An in vitro diagnostic medical device (IVD).Lot number: 149411
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source