Events

Recall of RAPIDEC CARBA NP

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
    31076
  • Event Risk Class
    III
  • Event Initiated Date
    2017-03-15
  • 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
    Confirmation of a screen printing error mentionned on the strips of the impacted lots. it is written that 5 ul must be pipetted and transferred to the wells "d" and "e". this information is wrong the right volume to transfer is 25 ul as specified in the instruction for use (ref. 20584 version e). this screen printing error could lead to a wrong protocol and pipetting 5 ul instead of 25 ul. when following the wrong protocol there is not issue for the carbapenamase positive strains all correctly identified as positive but there is a potential risk of false positive result for carbapenamase negative strains.

Device

RAPIDEC CARBA NP
  • Model / Serial
    Model Catalog: 415418 (Lot serial: 1005258400); Model Catalog: 417498 (Lot serial: 1005258400); Model Catalog: 415418 (Lot serial: 1005258740); Model Catalog: 417498 (Lot serial: 1005258740)
  • Product Description
    RAPIDEC CARBA NP
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.