Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - IGM 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
    76557
  • Event Risk Class
    III
  • Event Initiated Date
    2011-12-14
  • 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
    The vitros chemistry products igm reagent was put on a stop shipment hold pending the outcome of an investigation into an equipment malfunction that occurred in a temperatured controlled area but was erroneously shipped to ortho clincical diagnostics canada and later to its customers.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - IGM ASSAY
  • Model / Serial
    Model Catalog: 6801709 (Lot serial: 05-1572); Model Catalog: 6801734 (Lot serial: 05-1572); Model Catalog: (Lot serial: 20-1598)
  • Product Description
    VISTROS CHEMISTRY PRODUCTS IGM REAGENT
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS