Events

Recall of AEROSET SYSTEM - IMMUNOGLOBIN A 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
    87542
  • Event Risk Class
    III
  • Event Initiated Date
    2002-12-23
  • 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
    Abbott has conducted a mailing to all accounts with clarification of the reportable range.

Device

AEROSET SYSTEM - IMMUNOGLOBIN A ASSAY
  • Model / Serial
    Model Catalog: 9D98-01 (Lot serial: 0 82017HW00 78085HW00); Model Catalog: 9D98-01 (Lot serial: 93010HW00 90093HW00 86036HW0); Model Catalog: 9D98-01 (Lot serial: 73092HW00 70046HW00 68025HW0); Model Catalog: 9D98-01 (Lot serial: O.); Model Catalog: 9D99-01 (Lot serial: 93008HW00 90058HW00 87067HW0); Model Catalog: 9D99-01 (Lot serial: 0 87077HW00 86034HW00); Model Catalog: 9D99-01 (Lot serial: 80046HW00 75102HW00 73041HW0); Model Catalog: 9D99-01 (Lot serial: 0 71082HW00 71062HW00 71082); Model Catalog: 9D99-01 (Lot serial: HW00 6802HW00.); Model Catalog: 1E01-01 (Lot serial: 93027HW00 92036HW00 89107HW0); Model Catalog: 1E01-01 (Lot serial: 0 86085HW00 81038HW00); Model Catalog: 1E01-01 (Lot serial: 78019HW00 74058HW00 71062HW0); Model Catalog: 1E01-01 (Lot serial: 0 68014HW00.)
  • Product Description
    AEROSET IMMUNOGLOBIN A
  • 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