Events

Recall of ENVISION + SYSTEM/HRP RABBIT (DAB+)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OXOID (ELY) LIMITED.

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
    67277
  • Event Risk Class
    III
  • Event Initiated Date
    2005-11-28
  • 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
    A formulation error has occurred in the envision visualization reagent. when used quantitatively it will result in a reduction in intensity potentially leading to inappropriate exclusion for treatment.

Device

ENVISION + SYSTEM/HRP RABBIT (DAB+)
  • Model / Serial
    Model Catalog: K4011 (Lot serial: 075115); Model Catalog: K4009 (Lot serial: 065144); Model Catalog: K4011 (Lot serial: 055032); Model Catalog: K4010 (Lot serial: 055032); Model Catalog: K4011 (Lot serial: 035196); Model Catalog: K4010 (Lot serial: 035196); Model Catalog: K4011 (Lot serial: 075114); Model Catalog: K4010 (Lot serial: 075114); Model Catalog: K4011 (Lot serial: 055031); Model Catalog: K4010 (Lot serial: 055031); Model Catalog: K4011 (Lot serial: 035293); Model Catalog: K4010 (Lot serial: 035293); Model Catalog: K4007 (Lot serial: 075113); Model Catalog: K4006 (Lot serial: 075113); Model Catalog: K4007 (Lot serial: 045173); Model Catalog: K4006 (Lot serial: 045173); Model Catalog: K4007 (Lot serial: 075112); Model Catalog: K4006 (Lot serial: 075112); Model Catalog: K4007 (Lot serial: 045172); Model Catalog: K4006 (Lot serial: 045172); Model Catalog: K4002 (Lot serial: 065139); Model Catalog: K4003 (Lot serial: 045037); Model Catalog: K4002 (Lot serial: 045037); Model Catalog: K4000 (Lot serial:
  • Product Description
    Envision+System/HRP (DAB+)
  • Manufacturer
    OXOID (ELY) LIMITED

Manufacturer

OXOID (ELY) LIMITED
  • Manufacturer Address
    ELY
  • Source
    HC