Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYST.-RF(RHEUMATOID FACT.) ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    103418
  • Event Risk Class
    III
  • Event Initiated Date
    2011-11-11
  • 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
    Ortho clinical diagnostics (ocd) was notified by its supplier that lot 1630 of calibration kit 16 would not meet its specified 12-month stability. ocd testing indicates that patient results generated using vitros chemistry products rf reagent calibrated with vitros calibrator kit 16 lot 1630 may demonstrate a positive bias across the measuring range of 8.6-120 iu/ml if a new calibration is performed. the positive bias is readily identifiable by routine post-calibration quality control testing with control fluids. to date ocd has not received any complaints related to this issue.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYST.-RF(RHEUMATOID FACT.) ASSAY
  • Model / Serial
    Model Catalog: 6801700 (Lot serial: 1630)
  • Product Description
    VITROS Chemistry Calibration Kit 16
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS