Events

Recall of ARCHITECT I - 2ND GENERATION TESTOSTERONE REAGENT

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
    94615
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-09
  • 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
    On february 24 2016 a product deficiency was identified. testing performed to investigate complaint ticket 1061060r1715901 (received february 12 2016) confirmed the issue of obtaining the message "no assay" on the architect module display when using the new assay file and testing with architect 2nd generation testosterone reagent kit list number 2p13-28 lot 10458up00. a non-conformance report was opened on 24feb2016. preliminary root cause investigation was performed by tpm axis-shield diagnostics and identified the barcode for this lot was coded with the us assay file number instead of the ous assay file number. the information is hardcoded to the barcode on the microparticle bottle. therefore the customers are unable to test because the ous assay file does not recognize this lot with us assay file. axis shield has both assay files (us and ous) installed on their analyzer which is why the lot passed testing during manufacturing.

Device

ARCHITECT I - 2ND GENERATION TESTOSTERONE REAGENT

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