Events

Recall of VITROS CHEMISTRY PRODUCTS SYSTEM - CRP SLIDES (C-REACTIVE PROTEIN)

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
    31743
  • Event Risk Class
    III
  • Event Initiated Date
    2016-11-07
  • 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's investigation confirmed that samples diluted (3x recommended dilution or higher) using vitros chemistry products specialty diluent vitros chemistry products fs diluent pack 3 or a low crp concentration sample had positively biased results if the endogenous level of crp in the diluent is not subtracted from the final result.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - CRP SLIDES (C-REACTIVE PROTEIN)
  • Model / Serial
    Model Catalog: 809 7990 (Lot serial: > 10 Lots contact MFG); Model Catalog: 192 6740 (Lot serial: > 10 Lots contact MFG)
  • Product Description
    Vitros Chemistry Products System-CRP Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS