Events

Recall of Hemoglobin A1c (HbA1c) ReagentAn in vitro medical device.

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-01539-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01539-1
  • 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 has identified fetal hemoglobin (hbf) interference occurs at a level lower than what is stated in the hba1c reagent package insert. the package insert states that the hba1c assay is susceptible to interference effects from hbf at > 20%, while the most current data shows interference from hbf at > 5%. hba1c results are invalid for patients with abnormal amounts of hbf, including those with known hereditary persistence of fetal hemoglobin. in healthy adults, approximately 95% of hb is hba, with small amounts (<3.5%) of hba2 and hbf present.
  • Action
    Abbott is advising customers to be aware that falsely depressed results could occur when the HbF variant level in patient samples in >5%. Additional updates to the HbA1c reagent package insert will be provided to users once available.

Device

Hemoglobin A1c (HbA1c) ReagentAn in vitro medical device.

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