Events

Safety Alert for ARCHITECT Anti- HBc II Reagent

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott Laboratories Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-03-02
  • Event Date Posted
    2015-03-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150302b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: abbott laboratories architect anti- hbc ii reagent medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning architect anti- hbc ii reagent kit, with the following details: list number: 8l44-25; 8l44-30; 8l44-35; lot number: 42072li00; 42072li01; 42253li00; 42253li01; 42255li00; 42255li01; 42256li00 according to the manufacturer, the affected product shows lower calibrator, control and sample relative light unit (rlu) values, potentially leading to reduced specificity and increased false reactive results. internal testing showed specificity dropped to 99.2% which is below the package insert claim of 99.5% on a blood donor population. there is the potential for false reactive patient results but assay sensitivity is not impacted. the manufacturer advises users not to use the affected lots and destroy any remaining inventory of these lots according to their laboratory procedures. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 march 2015.

Device

ARCHITECT Anti- HBc II Reagent
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Laboratories ARCHITECT Anti- HBc II Reagent
  • Manufacturer
    Abbott Laboratories Ltd

Manufacturer

Abbott Laboratories Ltd
  • 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
    DH