Events

Recall of PLATELET ANTIBODY SCREENING KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTER MEDICO.

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
    29631
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-03
  • 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
    Anomalous decrease in the average optical density (od) results. during internal testing the average od values for the positive control were lower than expected in these lots. in most cases the lower reactivity led to invalid assay runs. in a few instances the assays were condisered valid but due to the lower than expected reactivity the sensitivity may have been decreased for samples with average od values near the assay cutoff.

Device

PLATELET ANTIBODY SCREENING KIT
  • Model / Serial
    Model Catalog: PAK12 (Lot serial: 101811P12)
  • Product Description
    LIFECODES Platelet Antibody Screening Kit
  • Manufacturer
    INTER MEDICO

Manufacturer

INTER MEDICO
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Inter Medico
  • Source
    HC