Events

Recall of LCX PROBE SYSTEM NEISSERIA GONORRHEA ASSAY (AMPLIFICATION)

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
    86260
  • Event Risk Class
    I
  • Event Initiated Date
    2002-07-31
  • 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
    Manufacturer has determined that the lots may not meet the analytical sensitivity) limit of dtection) of 10 colony forming units as decribed in the product insert.

Device

LCX PROBE SYSTEM NEISSERIA GONORRHEA ASSAY (AMPLIFICATION)
  • Model / Serial
    Model Catalog: 8A48-81 (Lot serial: 905M200 88097M300 88105M300); Model Catalog: 8A48-82 (Lot serial: M200 87818M100 87899M200 87); Model Catalog: 8A48-81 (Lot serial: M200 87818M100 87899M200 87); Model Catalog: 8A48-82 (Lot serial: O 87376M200 87377M200 87378); Model Catalog: 8A48-81 (Lot serial: O 87376M200 87377M200 87378); Model Catalog: 8A48-82 (Lot serial: 87225M100 87240M100 87243M10); Model Catalog: 8A48-81 (Lot serial: 87225M100 87240M100 87243M10); Model Catalog: 8A48-82 (Lot serial: 800M300 87007M400 87103M400); Model Catalog: 8A48-81 (Lot serial: 800M300 87007M400 87103M400); Model Catalog: 8A48-82 (Lot serial: M200 85488M200 85489M200 86); Model Catalog: 8A48-81 (Lot serial: M200 85488M200 85489M200 86); Model Catalog: 8A48-82 (Lot serial: 0 84146M300 85099M300 85487); Model Catalog: 8A48-81 (Lot serial: 0 84146M300 85099M300 85487); Model Catalog: 8A48-82 (Lot serial: 84073M400 84075M400 84142M30); Model Catalog: 8A48-81 (Lot serial: 84073M400 84075M400 84142M30); Model Catalog: 8A48-82 (Lot s
  • Product Description
    ABBOTT LCX NESSERIA GONNORRHOEAE 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