Events

Recall of Architect c4000, c8000, c16000 Cuvette Segment. 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-2017-RN-01501-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01501-1
  • 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 base of the architect cuvette segment may become detached under specific conditions. when a segment base is detached, cuvettes may be seated lower than the designed height. this may result in inadequate dispense into specific cuvettes due to the sample probe being unable to makeefficient contact with the cuvette bottom.Reasons for the bottom of the cuvette segment to detach are• excessive force applied during manual cleaning of cuvettes or cuvette wash tower crashes• lack of sufficient glue during cuvette segment manufacturing (c4000 and c8000 only)if a segment is detached, there is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the instrument. falsely depressed results may or may not be accompanied by a result flag.
  • Action
    Impacted patient results may be accompanied by “<” or “LOW” result flags, indicating that the result is below the linear range or the defined normal range of the assay, respectively. See ARCHITECT System Operations Manual Section 5: Operating Instructions for more information on patient result flags. Abbott is providing users with new instructions to avoid damaging the cuvette segments. A review of previously generated patient results is at the discretion of the Laboratory Manager,

Device

Architect c4000, c8000, c16000 Cuvette Segment. An in vitro diagnostic medical device (IVD)

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