Events

Recall of ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). 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
    Recall
  • Event ID
    RC-2015-RN-00598-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00598-1
  • 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 is issuing a field correction for a change in the concentration of n-acetylcysteine (nac) that may cause interference for the advia chemistry systems acetaminophen assay current lots and all future lots. the previous maximum nac concentration at which acceptable acetaminophen results were obtained was 800 mg/l. siemens has revised the concentration of nac at which acceptable results were obtained to 200 mg/l nac in an acetaminophen sample of approximately 661 µmol/l (10 mg/dl).
  • Action
    Siemens is advising end users of the change in the instructions for use regarding interference caused by NAC. The Instructions For Use (IFU) will be updated to reflect this change in interference.

Device

ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). An in vitro diagnostic medical de...
  • Model / Serial
    ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). An in vitro diagnostic medical device (IVD).Catalogue/Lot number – SMN 10327381, all current lots (see below) and all future lotsCurrent lots - 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157, 47558ARTG Number: 176646
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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