Events

Recall of Device Recall Human Lambda Free SPAPlus Kit

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
    76049
  • Event Risk Class
    Class 2
  • Event Number
    Z-1050-2017
  • Event Initiated Date
    2012-11-28
  • Event Date Posted
    2017-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152051
  • 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
    Calibration curve activity has increased over time in the kit lots listed.
  • Action
    Customer notification letters were sent 11/28/12. Customers were asked to discontinue using the listed kit lots. Discard any unused or partially-used kits of these lots. Let The Binding Site know how many replacement kits are required.

Device

Device Recall Human Lambda Free SPAPlus Kit
  • Model / Serial
    Lot #323278, 327963
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.
  • Product Description
    Human Lambda Free SPAPlus Kit || Product Code: LK018.S || Freelite aids in 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