Events

Recall of Liquid Specific Protein (LSP) Calibrator

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-2014-RN-01204-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01204-1
  • 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 observed an increased frequency of max fit deviation flags using the lsp calibrator kit lot 303574 (vial lots 122it – 127it) to calibrate the alpha-1-antitrypsin (aat) assay. the max fit deviation flag impacts the level 2 calibrator (123it) for the advia chemistry systems alpha-1-antitrypsin (aat) assay. while there is a potential for delay in alpha-1-antitrypsin results due to calibration failures, the risk to health as a result of this issue is negligible.- the lsp calibrator ifu version that resided on the siemens document library from december 10, 2013 until april 7, 2014contained preliminary calibrator values that differed slightly from the final calibrator values for the following advia chemistry systems assays: aag, aat, aso_2, c3, c4, frt, hapt, iga_2, igg_2, igm_2, prealb, rf and trf. the differences between either the final or preliminary calibrator values would not affect the utility of these tests in clinical practice.
  • Action
    Siemens is providing laboratories with the correct calibrator values.

Device

Liquid Specific Protein (LSP) Calibrator
  • Model / Serial
    Liquid Specific Protein (LSP) CalibratorCatalogue Number: 07711199Lot Number: 303574Expiry Date: Nov 2015An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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