Events

Recall of LAMBDA CELL TRAYS CLASS I

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
    107395
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-01
  • 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 identified lambda cell trays may produce high background results tests throughout the tray causing negative reactions to appear positive. the negative control serum utilized during analysis will alert users to the false reactions.

Device

LAMBDA CELL TRAYS CLASS I
  • Model / Serial
    Model Catalog: LCT1W60 (Lot serial: 027 LCT1W60 batch 060); Model Catalog: LCT1W60 (Lot serial: 4 units.)
  • Product Description
    Lambda Cell Tray
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC