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
  • Event ID
  • Event Risk Class
  • Event Initiated Date
  • Event Country
  • Event Source
  • 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 received reports of discoloured beads with light brown appearance in the product (should be white). probability of occurence is 1 in 1.4 million beads.


  • Model / Serial
    Model Catalog: 1236-25 (Lot serial: 85984M200.); Model Catalog: 1236 (Lot serial: 85984M200.); Model Catalog: 4A81-18 (Lot serial: 0.); Model Catalog: 4A81-18 (Lot serial: 88086HP00 85144HP00 83548HP0); Model Catalog: 7A92-36 (Lot serial: 88648M201 82180M101 82111M30); Model Catalog: 7A92-27 (Lot serial: 88648M201 82180M101 82111M30); Model Catalog: 7A92-26 (Lot serial: 88648M201 82180M101 82111M30); Model Catalog: 9006-24 (Lot serial: 1 83002M101.); Model Catalog: 9006-24 (Lot serial: 84767M301 86835M201 82300M20); Model Catalog: 9006-24 (Lot serial: M101 82843M101 85939M101); Model Catalog: 9006-24 (Lot serial: 1 86026M201 84768M301 84022); Model Catalog: 9006-24 (Lot serial: 86834M202 82841M101 88484M30); Model Catalog: 2A81 (Lot serial: M301.); Model Catalog: 2A81 (Lot serial: 1 84896M201 84283M201 85398); Model Catalog: 2A81 (Lot serial: 87026M401 88351M301 86279M20); Model Catalog: 2A81 (Lot serial: M301 87280M101 89525M200); Model Catalog: 2A81 (Lot serial: 1 86679M301 85021M401 88573); Model Catalog:
  • Product Description
  • Manufacturer


  • Manufacturer Address
  • Manufacturer Parent Company (2017)
  • 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