Recall of Alkaline Phosphatase (ALPAMP and ALPDEA), 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
    The affected lots demonstrate an increased incidence of absorbance flags, (u, u) and //// errors. absorbance flags u and u indicate abnormal high absorbance exceeding either the blank or sample limit. absorbance flag //// indicates a calculation error and no result is generated by the system.
  • Action
    Siemens Healthcare is advising customers to discontinue use and discard any affected lots. Replacement kits will be provided at free of charge. The increased rate of absorbance flags has not been associated with inaccurate results.


  • Model / Serial
    Alkaline Phosphatase (ALPAMP and ALPDEA), An in vitro diagnostic medical device (IVD)Test code: ALPAMPCatalogue number: 03035814Siemens Material Number: 10309049Lot numbers: 255406, 260121Test code: ALPDEACatalogue number: 03036535Siemens Material Number: 10341131Lot number: 255465ARTG 176331
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source