Events

Recall of VITEK 2 COMPACT 60 SYSTEM - INSTRUMENT

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
    56527
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-11
  • 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
    Within the current released versions of vitek 2 systems pc software (5.01 5.02 5.03 5.04 and 6.01) the breakpoints in the clsi parameter sets (which use the fda breakpoints) for ceftriaxone for b-hemolytic streptococci and viridans streptococci do not match the approved breakpoints from the current fda label.

Device

VITEK 2 COMPACT 60 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: HP D530 CAT.#W0438R (Lot serial: All serial numbers); Model Catalog: HP D530 CAT.#W0438 (Lot serial: All serial numbers); Model Catalog: HP RP5800 CAT.# 413642 (Lot serial: All serial numbers); Model Catalog: HP RP5800 CAT.# 413642R (Lot serial: All serial numbers); Model Catalog: HP RP5800 CAT.# 413862 (Lot serial: All serial numbers); Model Catalog: HP RP5700 CAT.# W0452 (Lot serial: All serial numbers); Model Catalog: HP RP5700 CAT.# W0452R (Lot serial: All serial numbers); Model Catalog: HP DC7800 CAT.# W0449 (Lot serial: All serial numbers); Model Catalog: HP D530 CAT.#W0437 (Lot serial: All serial numbers); Model Catalog: HP DC7100 W0441R (Lot serial: All serial numbers); Model Catalog: HP DC7100 W0441 (Lot serial: All serial numbers); Model Catalog: HP DC7700 W0447R (Lot serial: All serial numbers); Model Catalog: HP DC7700 CAT.# W0447 (Lot serial: All serial numbers); Model Catalog: HP DC7800 CAT.# W0449R (Lot serial: All serial numbers); Model Catalog: HP D530 CAT.# W0438R (Lot serial
  • Product Description
    PC FOR VITEK 2 COMPACT 60 SYSTEM
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.