Events

Recall of IL TEST FACTOR XII (HEMOSIL) DEFICIENT PLASMA

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

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
    85015
  • Event Risk Class
    III
  • Event Initiated Date
    2018-02-23
  • 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
    Hemosil factor xii deficient plasma are not meeting their labeled on-board instrument stability claim for the alc top family and acl top family 50 series of 24 hours at 15c the affected lots numbers are only stable for 2 hours on-board the instrument. consequently there is a potential risk of falsely lowered patient results if this reagent is maintain greater than 2 hours on-board the instrument.

Device

IL TEST FACTOR XII (HEMOSIL) DEFICIENT PLASMA
  • Model / Serial
    Model Catalog: 0020011200 (Lot serial: N0764104); Model Catalog: 0020011200 (Lot serial: N0958653); Model Catalog: 0020011200 (Lot serial: N0556645); Model Catalog: 0020011200 (Lot serial: N1065905); Model Catalog: 0020011200 (Lot serial: N0261273)
  • Product Description
    HEMOSIL FACTOR XII DEFICIENT PLASMA
  • Manufacturer
    INSTRUMENTATION LABORATORY CO.

Manufacturer

INSTRUMENTATION LABORATORY CO.
  • Manufacturer Address
    BEDFORD
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    HC