Events

Recall of PARVOVIRUS B19 IGM DXSELECT

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

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
    85524
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-16
  • 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
    An internal investigation has confirmed that the shelf life of the product does not meet the expiration dating of 24 months. the expiration prediction intervals from each of the product lots cross the limit at 12 months past date of manufacture including a safety margin.

Device

PARVOVIRUS B19 IGM DXSELECT
  • Model / Serial
    Model Catalog: EL0100M (Lot serial: X32894); Model Catalog: EL0100M (Lot serial: X33186); Model Catalog: EL0100M (Lot serial: X33688); Model Catalog: EL0100M (Lot serial: X31251); Model Catalog: EL0100M (Lot serial: X32120)
  • Product Description
    Parvovirus B19 IgM DxSelect
  • Manufacturer
    DIASORIN MOLECULAR LLC

Manufacturer

DIASORIN MOLECULAR LLC
  • Manufacturer Address
    CYPRESS
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    HC