Events

Recall of LABSCREEN PRA CLASS II

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

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
    83392
  • Event Risk Class
    II
  • Event Initiated Date
    2012-09-08
  • 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
    A false reaction may be observed with the dp20 antigen provided with lots #007-008. in addition the reference molecular typing provided on the lot specific user documents (lots 003-008) are incorrectly identified.

Device

LABSCREEN PRA CLASS II
  • Model / Serial
    Model Catalog: LS2A01 (Lot serial: 003004005006007008)
  • Product Description
    LABScreen Product - LABScreen Single Antigen HLA Class II Antibody Detection Test GROUP 1
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC