Events

Recall of LABTYPE SSO DRB1 TYPING TEST

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
    67167
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-31
  • 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
    Lot specific user documents and software catalog file for rssoh2b1 lot 009 (batches 1-36) are incorrect. allele information on the lot specific user documents and software catalog file is missing.

Device

LABTYPE SSO DRB1 TYPING TEST
  • Model / Serial
    Model Catalog: RSSOH2B1 (Lot serial: 009 BATCHES 001-036)
  • Product Description
    LABType HD DRB1 Typing Test
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC