Events

Recall of Sekisui Diagnostics Acetaminophen Reagent. 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 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-2015-RN-00389-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00389-1
  • 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 current instructions for use reports the interference from n-acetylcysteine (nac) evaluated on a commercially available analyser. using a significance criterion of > 10% variance from control, acceptable results were obtained to a level of 800 mg/l n-acetylcysteine (nac) in a 104 ìg/ml (688 ìmol/l) acetaminophen sample; this in vitro analysis was performed approximately two hours after the addition of nac to a serum pool.Based on testing performed by sekisui diagnostics on an architect csystems instrument, the concentration of nac at which acceptable acetaminophen results are obtained is 200 mg/l nac in values from a 109 ìg/ml acetaminophen sample, tested two hours after the addition of nac to a serum pool.The package insert is being updated accordingly based on these results.
  • Action
    Laboratories are advised that treatment with N-acetylcysteine (NAC) could interfere with the assay to a greater extent than previously indicated resulting in negative bias. The Instructions for Use have been updated with this warning. Laboratories are advised to follow their protocols regarding the need for review of previously reported results. This action has been closed-out on 18/04/2017.

Device

Sekisui Diagnostics Acetaminophen Reagent. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Sekisui Diagnostics Acetaminophen Reagent. An in vitro diagnostic medical device (IVD)List Number: 2K99-20Lot Number: 45797UQ04Expiration Date: 30-JUN-2015Lot Number: 46121UQ07Expiration Date: 30-SEP-2015Lot Number: 46561UQ08Expiration Date: 31-OCT-2015Lot Number: 46207UQ09Expiration Date: 30-NOV-2015Lot Number: 46953UQ12Expiration Date: 29-FEB-2016
  • 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