Events

Recall of QUANTIKINE IVD HUMAN B2-MICROGLOBULIN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by R & D SYSTEMS INC.

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
    44983
  • Event Risk Class
    II
  • Event Initiated Date
    2009-05-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    During manufacturing it was found the standard used to calibrate the assay may have evaporated in some vials. if evaporation occurs this will cause the standards to read erroneously.

Device

QUANTIKINE IVD HUMAN B2-MICROGLOBULIN
  • Model / Serial
    Model Catalog: (Lot serial: 260980)
  • Product Description
    QUANTIKINE IVD HUMAN B2-MICROGLOBULIN
  • Manufacturer
    R & D SYSTEMS INC

Manufacturer

R & D SYSTEMS INC
  • Manufacturer Address
    MINNEAPOLIS
  • Source
    HC