Events

Field Safety Notices about ARCHITECT CA 19-9XR

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Abbott Laboratories.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2012(07)
  • Date
    2012-06-21
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/architect-ca-19-9xr&id=ed7ef825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    Abbott has determined that architect ca 19-9xr reagent lots 08849m500, 08851m500, 08852m500, 08853m500, 10122m500 and 10040m500 are demonstrating an upward shift in patient results. abbott has advised that through their investigations, a positive median bias of 83% has been observed when compared to other architect ca 19-9xr lots. the manufacturer advised that this issue may impact patient management when affected lots are used for monitoring patients.
  • Action
    The IMB recommends that:  1. Customers consider the information in the FSN regarding the magnitude of the bias observed over the range of the assay (0-365%) and the need to review patient results.  2. Customers who determine the need to conduct a look back study and require further information in relation to this issue should contact Abbott for further advice. A copy of the FSN is also available on the HPRA website at the following link:  Urgent Field Safety Notice - V14968

Device

ARCHITECT CA 19-9XR

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
    HPRA