Events

Recall of FREELITE" Human Lambda Free Kit for use on the SPAplus"

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Binding Site Group, Ltd..

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
    76050
  • Event Risk Class
    Class 2
  • Event Number
    Z-1053-2017
  • Event Initiated Date
    2016-10-28
  • Event Date Posted
    2017-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152052
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lambda, antigen, antiserum, control - Product Code DEH
  • Reason
    A change in the calibration curve causing an increase in false prozone flags.
  • Action
    Binding Site sent an Important Notice dated October 28, 2016, to all affected customers. . Binding Site requests the following: - Immediately quarantine and dispose of any LK018.S lot 400012 / LK018.10S lot 400257 kits held in your organisation; - Remove any affected lots from the SPAPLUS instrument; - Contact Binding Site representative to request replacement kits; - Return completed E-back form to your local Binding Site representative. For questions regarding this recall call 858-453-9177.

Device

FREELITE" Human Lambda Free Kit for use on the SPAplus"
  • Model / Serial
    Lot #400012, 400257
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
  • Product Description
    Freelite Human Lambda Free Kit for use on SPAPLUS || Product Code: LK018.S, LK018.10S || Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
  • Manufacturer
    The Binding Site Group, Ltd.

Manufacturer

The Binding Site Group, Ltd.
  • Manufacturer Address
    The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
  • Manufacturer Parent Company (2017)
    Cidron Iugo Sarl
  • Source
    USFDA