Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - MALB (ALBUMIN) 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
    144351
  • Event Risk Class
    III
  • Event Initiated Date
    2011-11-01
  • 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) has received complaints of lower than expected results for control fluids and patient samples upon initial calibration or following recalibration using vitros chemistry products calibrator kit 24 and vitros chemistry products malb reagent. all current lots of vitros calibrator kit 24 may experience a change in performance over time which will yield lower than expected results when they are used to calibrate all current gens of vitros malb reagent.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - MALB (ALBUMIN) ASSAY
  • Model / Serial
    Model Catalog: 6801708 (Lot serial: all)
  • Product Description
    VITROS Chemistry Products Calibrator Kit 24
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS