Events

Recall of ADVIA Centaur, Dimension Vista & Immulite Systems - Assay: ADVIA Centaur Progesterone; Assay: Dimension Vista LOCI Progesterone; Assay: Immulite/Immulite 1000 Progesterone; Assay: Immulite 2000 Progesterone

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-2017-RN-00039-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-01-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00039-1
  • 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 presence of dhea-s (a metabolite of dhea, a steroid hormone that may be used as part of in vitro fertilisation (ivf) protocols to improve ovarian response and ivf treatment outcomes) causes falsely elevated progesterone results on certain platforms around the clinically important decision level of approximately 1 ng/ml (3.18 nmol/l) of progesterone. this threshold is used by some ivf protocols to determine whether to proceed with fresh embryo transfer in the current cycle.
  • Action
    Affected assays should not be used to report results for patients who are taking DHEA supplements. For patients taking DHEA supplements, an alternate method such as Liquid Chromatography-Mass Spectroscopy (LCMS) which is not expected to show cross reactivity to DHEA-S should be used to measure progesterone concentrations. Siemens’ Progesterone assays may continue to be used to report results for patients who are not taking DHEA supplements. A review of previously generated results is at the discretion of the laboratory.

Device

ADVIA Centaur, Dimension Vista & Immulite Systems - Assay: ADVIA Centaur Progesterone; Assay: Dim...
  • Model / Serial
    ADVIA Centaur, Dimension Vista & Immulite SystemsAssay: ADVIA Centaur ProgesteroneTest Code: PRGECatalogue/SMN # 10310305, 10315522, 10333111Assay: Dimension Vista LOCI ProgesteroneTest Code: PROGCatalogue: K6464SMN: 10461743Assay: Immulite/Immulite 1000 ProgesteroneTest Code: PRGCatalogue: LKPW1SMN: 10381128Assay: Immulite 2000 ProgesteroneTest Code: PRGCatalogue: L2KPW2, L2KPW6SMNs: 10381181, 10381170All LotsARTG # 175698, 180109, 179720
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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