Events

Recall of ARCHITECT "I" SYSTEM - CA 19-9XR ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ABBOTT LABORATORIES LIMITED. 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
    38406
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-01
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    A product deficiency was identified due to a shift up in patient results when using architect ca 19-9xr assay lot numbers 08851m500 08853m500 and 10040m500. these lots are demonstrating a shift up in patient results. abbott controls however do not detect the upward shift and will test within range. all other in-date reagent lots are not affected by the shift. the impacted lots all share the same conjugate component.

Device

ARCHITECT "I" SYSTEM - CA 19-9XR ASSAY
  • Model / Serial
    Model Catalog: 2K91-20 (Lot serial: 08851M500); Model Catalog: 2K91-25 (Lot serial: 08851M500); Model Catalog: 2K91-20 (Lot serial: 08853M500); Model Catalog: 2K91-25 (Lot serial: 08853M500); Model Catalog: 2K91-20 (Lot serial: 10040M500); Model Catalog: 2K91-25 (Lot serial: 10040M500)
  • Product Description
    ARCHITECT "I" SYSTEM - CA 19-9XR ASSAY
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • Manufacturer Address
    MISSISSAUGA
  • 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
    HC