Events

Recall of Device Recall Beta2Microglobulin Urine 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
    79499
  • Event Risk Class
    Class 2
  • Event Number
    Z-1301-2018
  • Event Initiated Date
    2018-03-09
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162483
  • 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
    System, test, beta-2-microglobulin immunological - Product Code JZG
  • Reason
    The product is not meeting the antigen excess protection claim of up to 760mg/l, as stated in the instructions for use.
  • Action
    The recalling firm notified their U.S. location by letter dated 3/6/2018 via email on 3/9/2018.

Device

Device Recall Beta2Microglobulin Urine Kit
  • Model / Serial
    Lot 407460, UDI 05051700017688
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution was made to CA. There was no foreign/military/government distribution.
  • Product Description
    Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. || The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.
  • 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