Events

Recall of ADVIA Chemistry Systems, Alkaline Phosphate (ALPAMP) Reagent Kits

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
    Recall
  • Event ID
    RC-2013-RN-00693-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-07-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00693-1
  • 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
    Siemens has confirmed that the affected lots demonstrate an increased incidence of absorbance flags (u, u) and //// errors.
  • Action
    Siemens is requesting their customers to discontinue use and discard any reagents from the affected lot. Kits will be replaced at no charge. A look back at previously reported results is at the discretion of the testing laboratory.

Device

ADVIA Chemistry Systems, Alkaline Phosphate (ALPAMP) Reagent Kits
  • Model / Serial
    ADVIA Chemistry Systems, Alkaline Phosphate (ALPAMP) Reagent KitsCatalogue Number: 03035814Siemens Material Number: 10309049Lot Numbers: 267774 & 271674Expiration Date: 2013-12ARTG Number: 176331
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA