Events

Recall of Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems Alkaline Phosphatase ALPAMP

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

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-2015-RN-00961-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00961-1
  • 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
    The reagent kit lots listed above 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.The increased rate of absorbance flags with these lots has not been associated with inaccurate results. if calibration and quality control results are acceptable, reported patient results are acceptable. this risk to health is negligible. siemens advises the potential for clinical impact and overall risk to health as a result of this issue is negligible.
  • Action
    Customers are asked to quarantine affected units from use prior to destruction and/or disposal.

Device

Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XP...
  • Model / Serial
    Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems Alkaline Phosphatase ALPAMPCatalogue Number: 03035814Lot Number: 327460Alkaline Phosphatase ALPDEACatalogue Number: 03036535Lot Number: 327465 Alkaline Phosphatase Concentrated ALPA_cCatalogue Number: 06860450Lot Number: 327471ARTG Number: 176331
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA