Events

Recall of Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). 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-2016-RN-01374-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01374-1
  • 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 for several lots the currently assigned dbil_2 assigned calibrator values (acvs) may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement. quality control (qc) material is also affected by this issue. depending on the quality control concentrations and ranges used by the laboratory, quality control may not detect this issue. the positive bias may lead to an overestimation of direct bilirubin and the potential for further monitoring or confirmation of a potentially abnormal direct bilirubin finding during the assessment of liver dysfunction and/or during the investigation of jaundice. to correct the positive bias and restore alignment to the reference method, the acv for dbil_2 has been reassigned from 77 micromol/l to 55 micromol/l. all other analytes present in the chemistry calibrator meet product standards.
  • Action
    Siemens is advising users to use the reassigned DBIL_2 ACVs for the affected Chemistry Calibrator lot numbers. In addition, laboratories should review the targets and ranges for quality controls used with the DBIL_2.

Device

Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vit...
  • Model / Serial
    Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vitro diagnostic medical device (IVD).ADVIA Chemistry CalibratorSiemens Material Number (SMN): 10312279 Lot Numbers: 680726 (exp. 2017-06), 680726A (exp. 2017-09), 680726B (exp. 2017-09), 680726C (exp. 2018-02), 680726D (exp. 2018-02)ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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