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
    31772
  • Event Risk Class
    II
  • Event Initiated Date
    2012-10-31
  • 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
    The user documenation for this product is missing drb1*15:50n allele for probe on bead #525. this may generate a sample typing of drb1*15:04 instead of drb1*15:04/15:50n. there is low risk of death or serious harm to the patient orend user as a result of this potential product failure.

Device

LABTYPE SSO DRB1 TYPING TEST
  • Model / Serial
    Model Catalog: RSSOH2B1X (Lot serial: 07B); Model Catalog: RSSOH2B1 (Lot serial: 07B)
  • Product Description
    LABType HD Class II DRB1 Typing Test
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC