Events

Recall of ADVIA Chemistry Systems Lipase Assay

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-2015-RN-00269-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00269-1
  • 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 healthcare diagnostics has identified the potential for positive biase of advia chemistry systems lipase assay results due to carry-over from one or more of the following tests: · triglycerides, · triglycerides _2, · triglycerides concentrated, · cholesterol concentrated, and · direct ldl reagents. the carryover potential from these reagents is mitigated by setup of designated contamination avoidance protocols. however, in certain circumstances, rare incidences of carryover interference can occur.
  • Action
    Siemens is actively investigating this situation in an effort to provide an improved contamination avoidance protocol for the Lipase assay to eliminate high-biased ADVIA Chemistry Systems Lipase assay results. Siemens has provided customers with a work around to mitigate this problem from occurring. This action has been closed-out on 01/03/2018.

Device

ADVIA Chemistry Systems Lipase Assay
  • Model / Serial
    ADVIA Chemistry Systems Lipase AssayCatalogue Number: B01-4840-01, REF: 01984894Siemens Material Number: 10311896All lot number affectedARTG Number: 176331
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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