Events

Safety Alert for ARCHITECT CA 19-9XR

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

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
    2012-06-04
  • Event Date Posted
    2012-06-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120604b.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 architect ca 19-9xr medical device manufacturer, abbott laboratories issued a safety alert concerning certain lots of architect ca 19-9xr reagent. abbott has confirmed that these six architect ca 19-9xr reagent lots are demonstrating a shift up in patient results. an internal investigation is in process. initial indications suggest that the issue is caused by the conjugate component as all lots identified above share the same conjugate component. this issue may impact patient management when affected lots are used in monitoring of patients. therefore, abbott advised users to stop using the affected units and destroy any remaining inventory of the lots listed above. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 4 june 2012.

Device

ARCHITECT CA 19-9XR
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott ARCHITECT CA 19-9XR
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 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