Events

Recall of LIFECODES LIFESCREEN DELUXE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IMMUCOR GTI DIAGNOSTICS 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
    75025
  • Event Risk Class
    III
  • Event Initiated Date
    2015-10-15
  • 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
    During in-house stability testing at test point 9 months with lmx lot 3002350 we observed false positive results with a single sample. the sample is expected to test negative for both hla class i and class ii. the sample gave a qualitative result of ci (-) cii (+) indicating a false positive for hla class ii.

Device

LIFECODES LIFESCREEN DELUXE
  • Model / Serial
    Model Catalog: 628215 (Lot serial: 3002350)
  • Product Description
    LIFECODES LifeScreen Deluxe (LMX)
  • Manufacturer
    IMMUCOR GTI DIAGNOSTICS INC.

Manufacturer

IMMUCOR GTI DIAGNOSTICS INC.
  • Manufacturer Address
    WAUKESHA
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC