Events

Recall of ID-MICRO TYPING SYSTEM - ANTI-IGG CARD

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
    52600
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-02
  • 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
    Ortho clinical diagnostics (ortho) has initiated a recall due to the potential for false positive reactions when using specific lots of anti-human globulin anti-igg (rabbit) mts anti-igg cards (mts anti-igg cards). it has been determined that affected mts anti-igg card lots may exhibit a varying low-level activity of anti-complement that may result in a false positive test.

Device

ID-MICRO TYPING SYSTEM - ANTI-IGG CARD
  • Model / Serial
    Model Catalog: MTS084024 (Lot serial: 101216001-53); Model Catalog: MTS084024 (Lot serial: 101216001-58); Model Catalog: MTS084024 (Lot serial: 101216001-56); Model Catalog: MTS084024 (Lot serial: 101216001-55); Model Catalog: MTS084024 (Lot serial: 101216001-57); Model Catalog: MTS084024 (Lot serial: 101216001-51); Model Catalog: MTS084024 (Lot serial: 101216001-50); Model Catalog: MTS084024 (Lot serial: 101216001-60)
  • Product Description
    Anti-Human Globulin Anti-IgG (Rabbit) MTS Anti-IgG Card
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS