Events

Recall of Amylase Assay used with ADVIA Chemistry Systems

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-00340-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00340-1
  • 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 that the affected amylase reagent kit demonstrate an increased incidence of absorbance flags (u or u accompanied by u). absorbance flags (u) indicate an abnormally high reagent blank absorbance exceeding the reagent blank limit. in some cases with these reagent lots, sample results may also have a sample absorbance (u) flag indicating a high absorbance for the sample that occurs in conjunction with the (u) flag. amylase results can be generated with these flags. the risk to health is limited to a potential delay in amylase testing.
  • Action
    Siemens is advising users that if a sample (u) flag occurs where there are no absorbance (U) flags, the flag is sample related and the sample should be re-tested. Siemens is advising users who choose not to continue using the affected batches, that Siemens will replace the affected lots. The look back of previously generated results is at the discretion of the laboratory. This action has been closed-out on 07/09/2016.

Device

Amylase Assay used with ADVIA Chemistry Systems
  • Model / Serial
    Amylase Assay used with ADVIA Chemistry SystemsTest Code: AMYLASCatalogue Numbers: 07498401 & 03031177Siemens Material Numbers: 10309493 & 10341130Lot Numbers: 304821 & 304816Expiration Date: April 2015 ARTG number: 176331An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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