Events

Recall of PREVI ISOLA SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX CANADA INC..

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
    42391
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-03
  • 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
    It has been determined that the pipettor may fail in very few cases (less than 1%) to dispense a urine sample due to a sample ''wicking'' where the dispensed sample remains adhered to the side of the pipette tip rather than dropping to the agar surface. in such cases the first plate may have no sample dispensed and a double volume may be dispensed on the next plate if a multiple plate panel is being used.

Device

PREVI ISOLA SYSTEM
  • Model / Serial
    Model Catalog: AS180-00001 TO AS180-00476 (Lot serial: >100 contact mfg)
  • Product Description
    PREVI Isola
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.