Events

Recall of ACCU-MAB PLUS BORDETELLA PERTUSSIS / PARAPERTUSSIS DFA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DELTA BIOTECH 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
    71624
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-17
  • 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
    Declining fluorescence for bordetella pertussis. false negative results for bordetella parapertussis. bordetella parapertussis falsely identified as bordetella pertussis. when reagent is used neat (undiluted) it may cause the bacteria smear to detach from the glass microscope slide resulting in no visible fluorescence.

Device

ACCU-MAB PLUS BORDETELLA PERTUSSIS / PARAPERTUSSIS DFA
  • Model / Serial
    Model Catalog: 4020-BP002-01 (Lot serial: 01183); Model Catalog: 4020-BP002-01 (Lot serial: 10253)
  • Product Description
    AccuMAb Plus Bordetella pertussis /parapertussis DFA
  • Manufacturer
    DELTA BIOTECH INC.

Manufacturer

DELTA BIOTECH INC.