Events

Recall of ID-MICRO TYPING SYSTEM - INSTRUMENTATION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    77742
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-15
  • 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
    As an expansion to recall id 79537 ocd has recalled 3 lots of mts anti-igg card (mts084024) based on customer complaints of incomplete foil seals on the gel cards. although internal investigation demonstrated acceptable peel strength for the 3 affected lots and no complaints of erroneous results have been reported due to this issue ocd would like to remind users to inspect their gel cards upon receipt (as instructed by the product labeling).

Device

ID-MICRO TYPING SYSTEM - INSTRUMENTATION
  • Model / Serial
    Model Catalog: MTS084024 (Lot serial: 090612001-11); Model Catalog: MTS084024 (Lot serial: 090612001-15); Model Catalog: MTS084024 (Lot serial: 090612001-05)
  • Product Description
    MTS Anti-IgG Card
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS