Events

Recall of Abbott RealTime HIV-1 Assay. 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 Molecular 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-01057-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01057-1
  • 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
    Abbott molecular has identified that a specific lot of abbott realtime hiv-1 assay may exhibit a higher than expected rate of error codes. for plasma samples, this has the potential to exhibit false “not detected” results for hiv samples less than 120 copies/ml when using 0.6 ml assay application. for dried blood spot (dbs) samples when using a 1-spot protocol associated with the realtime hiv-1 package insert 51-608282, these are performing in accordance with the detection rate within the realtime hiv-1 package insert for dbs sample types.
  • Action
    Abbot is requesting users: 1. Review the supplied Abbott Molecular letter carefully and follow the instructions; 2. Complete and return the supplied Customer Reply Form; 3. Contact Abbott Customer Service for assistance if needed. If customers have forwarded the affected product to other laboratories, inform them of this Product Recall and provide to them a copy of the customer letter; and 4. Retain this letter for your laboratory records.

Device

Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD)

Manufacturer

Abbott Australasia Pty Ltd Molecular 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