Events

Recall of ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. 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 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-00488-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00488-1
  • 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
    An internal investigation by siemens has identified that certain lots of the advia centaur systems insulin (iri) assay recover approximately 40% higher than the world health organisation (who) 1st irp 66/304 standardisation based on slope values. the slope value was observed to be 1.40 on the advia centaur xp and 1.42 on the advia centaur cp. the potential exists for misinterpretation of insulin levels when comparing to the who standard. siemens has confirmed that the assay’s reportable range, reference interval, precision, analytical sensitivity, hook effect and linearity are not impacted by this issue and continue to meet the assay performance characteristics as stated in the instructions for use.
  • Action
    Siemens is advising users that standardisation to WHO 1st IRP 66/304 has been restored beginning with ADVIA Centaur IRI ReadyPack kit lots ending in 201 and IRI Calibrator kit lots ending in 02, which will be available by May 2017. In the interim, users can continue to use existing product to report results and should ensure that clinicians are made aware that results will be approximately 40% higher than the WHO 1st IRP 66/304 material. Upon receipt of ADVIA Centaur Systems Insulin ReadyPack kit lots ending in 201 (and future lots) and IRI Calibrator kit lots ending in 02 (and future lots), users are discontinue use of the affected product. The Bio-Rad website should be referred to for revised control targets and ranges to be used with corrected product. For all other commercially available controls, evaluate the need for target reset. Further details regarding expected performance are detailed in the customer letter.

Device

ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. An in vitro diagnostic medical device ...
  • Model / Serial
    ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. An in vitro diagnostic medical device (IVD)Insulin CalibratorTest Code: Calibrator IRICatalogue #: 04618899SMN: 10310438Kit Lots ending in: 59 (exp 05 Apr 17), 67 (exp 22 Aug 17), 70 (exp 27 Nov 17), 74 (exp 26 Feb 17)Insulin ReadyPackTest Code: IRICatalogue #: 02230141SMN: 10310439Kit Lots ending in: 169 (exp 11 Apr 17), 170 (exp 27 May 17), 173 (exp 30 Jun 17), 174 (exp 26 Aug 17)ARTG Number: 175698
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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