Events

Recall of LABSCREEN CLASS I SINGLE ANTIGEN GROUP 1

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
    73925
  • Event Risk Class
    III
  • Event Initiated Date
    2011-08-24
  • 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 maybe observed with the mica019 antigen. upon investigation trnsfected mica 019 cell lines (rc1223) demonstrated a lack of or presence of recombinant mica019 inserts.

Device

LABSCREEN CLASS I SINGLE ANTIGEN GROUP 1
  • Model / Serial
    Model Catalog: LSMICA001 (Lot serial: LSMICA001 003); Model Catalog: LSMICA001 (Lot serial: LSMICA001 004); Model Catalog: LSMICA001 (Lot serial: LSMICA001 002)
  • Product Description
    LABScreen Product-LABScreen MICA Single Antigen -Group 1
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC