Events

Recall of SCREEN-CYTE (REAGENT RED BLOOD CELLS)

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
    107311
  • Event Risk Class
    III
  • Event Initiated Date
    2017-06-23
  • 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
    The manufacturer medion grifols diagnostics ag has become aware through their routine vigilance process that the antigen table provided with this product contains an error. the error affects the lub antigen in the first cell (donor 0124624) of the screen-cyte 0.8% and screen-cyte p 0.8% antigen panels lot 17011. specifically the table shows that cell 1 has a negative typing "0" for lub antigen while the actual value is positive "+.".

Device

SCREEN-CYTE (REAGENT RED BLOOD CELLS)
  • Model / Serial
    Model Catalog: 213590 (Lot serial: 17011); Model Catalog: 213665 (Lot serial: 17011)
  • Product Description
    SCREEN-CYTE 0.8% REAGENT RED BLOOD CELLS
  • Manufacturer
    INTER MEDICO

Manufacturer

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