Events

Recall of VITROS ECI IMMUNODIAGNOSTIC INTACT PTH REAGENT PACK

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
    120903
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-12
  • 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 confirmed that results obtained from vitros ipth reagent packs are positively biased (i.E. falsely elevated) compared to an alternative commercially available method. ortho observed a positive bias of 40% for samples with ipth concentrations <100pg/ml when testing with vitros ipth reagent packs in comparison to the roche elecsys pth test. ortho data demonstrated that this bias was consistent for all in-date lots.

Device

VITROS ECI IMMUNODIAGNOSTIC INTACT PTH REAGENT PACK
  • Model / Serial
    Model Catalog: 680 2893 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2892 (Lot serial: > 10 contact manufacturer)
  • Product Description
    VITROS Immunodiagnostic Products Intact PTH (Reagent Pack & Calibrators)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS