Events

Recall of Device Recall Optilite Freelite Lambda Free 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
    76048
  • Event Risk Class
    Class 2
  • Event Number
    Z-1043-2017
  • Event Initiated Date
    2016-07-05
  • Event Date Posted
    2017-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152050
  • 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
    Batch numbers listed are reporting lambda free light chain results >114mg/l that are on average 33% lower than other optilite lambda freelite batches. therefore users moving to this batch will see results >114mg/l giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
  • Action
    On 07/05/16 notification letters were sent to customers. The Binding Site Group requests the following: - Immediately Quarantine & Dispose of any LK018.OPT lot 405566 kits within stock; - Remove any affected lots from the Optilite instrument; - Patients with Lambda Freelite results >114mg/L should be reviewed in consultation with clinicians, alongside other clinical findings and retested where applicable; - Notify local Binding Site representative to request replacement kits; - Return completed E-Back Form to local Binding Site Representative; The firm recommended that the notice be circulated to those within the organization who need to be aware.

Device

Device Recall Optilite Freelite Lambda Free Kit
  • Model / Serial
    Lot #405566, 405567
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.
  • Product Description
    Optilite Freelite Lambda Free Kit || Product Code: LK018.OPT, LK018.OPT.A || Protein testing kit.
  • 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