Events

Recall of Lipase Reagent (diagnostic good for the quantitation of lipase in human serum or plasma)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abbott Australasia Pty Ltd Diagnostic 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-00423-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00423-1
  • 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
    The lipase reagent package insert for the lots above has incorrect information regarding the required cuvette smartwash for triglyceride. the insert indicates that the triglyceride cuvette smartwash assay parameter is not required on architect system software version 7.00 or higher; however, the triglyceride smartwash is required for the lipase assay on all software versions. the insert is correct beginning with lot 45200uq12.
  • Action
    End users are advised to verify that Lipase assay parameters on ARCHITECT cSytems are configured for a Trig (Trigylceride) Cuvette SmartWash with 345 volume of 10% Detergent B. If the Lipase SmartWash for Trigylceride is not configured, immediately update the parameter by adding a Trig (Trigylceride) Cuvette SmartWash with 345 volume of 10% Detergent B. Thia action has been closed on 28/01/2016.

Device

Lipase Reagent (diagnostic good for the quantitation of lipase in human serum or plasma)
  • Model / Serial
    Lipase Reagent (diagnostic good for the quantitation of lipase in human serum or plasma)Lot Numbers: 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, 44930UQ11
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Abbott Australasia Pty Ltd Diagnostic Division
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA