Events

Recall of ADVIA Centaur Systems Progesterone 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-2015-RN-00088-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00088-1
  • 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 confirmed a high bias on results greater than 30 ng/ml (95.4 nmol/l) when compared to the master curve when using the affected advia centaur progesterone kit lots. the high bias may cause neat serum samples with results greater than 60 ng/ml (190.8 nmol/l) to recover within the assay range upon dilution (dilution factor applied). on the advia centaur systems, for samples greater than 30 ng/ml (95.4 nmol/l), customers may observe an average dilution recovery between 48.3% and 105.0%. samples (both neat and diluted) with values below 30 ng/ml (95.4 nmol/l) do not demonstrate this bias.Progesterone values above 30 ng/ml (95.4 nmol/l) are indicative of pregnancy. the difference in neat values compared to diluted values will not change the clinical interpretation of the results. siemens advises that the severity of potential injury is negligible and the overall risk to health is negligible to non-existent. no laboratory look back is recommended.
  • Action
    A workaround is provided to customers regarding dilution of samples for lots ending in 268 only. Technical Specialist contact number details are also provided for users as ongoing support. This action has been closed-out on 06/09/2016.

Device

ADVIA Centaur Systems Progesterone Kits
  • Model / Serial
    ADVIA Centaur Systems Progesterone KitsTest Code: PRGEKit Lot Numbers: Ending in 268Catalogue Numbers: 02382928 (1-pack), 01586287 (5-pack), 02177364 (5-pack Ref)Expiration Date: May 22, 2015ARTG Number: 175698
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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