Events

Recall of Device Recall Optilite IgG4 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
    76131
  • Event Risk Class
    Class 3
  • Event Number
    Z-1089-2017
  • Event Initiated Date
    2016-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152264
  • 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
    Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
  • Reason
    A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert.
  • Action
    Customer notification letters were sent on 12/23/16. The Binding Site recommends to continue testing on the kit as normal and refer to the measuring ranges and limit of quantification stated in the notice and as indicated in the amended insert (INS009.OPT.A, Version: 21st December 2016) provided with this notification. The notice needs to be passed on to all those who need to be aware within the organization or to any Organization where the potentially affected devices have been transferred. Return the completed E-Back Form to your local Binding Site Representative for records and note that The Binding Site intends to report this correction to the FDA recall coordinator. If you have any questions contact Technical Services.

Device

Device Recall Optilite IgG4 Kit
  • Model / Serial
    Lot #401413
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
  • Product Description
    Optilite IgG4 Kit || Product Code: LK009.OPT.A
  • 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