Events

Recall of CALAPP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BUHLMANN DIAGNOSTICS CORP..

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
    104021
  • Event Risk Class
    II
  • Event Initiated Date
    2018-03-15
  • 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
    In isolated cases ashifted test line of the ibdoc lateral flow test cassette falls outside of the read-out window of the calaoo interpretative software. the result is incorrectly interpreted as test line to control line ratio of 0 and a normal calprotectin value <30 microgram/gram.

Device

CALAPP
  • Model / Serial
    Model Catalog: CALAPP (Lot serial: N/A); Model Catalog: LF-IBDOC8 (Lot serial: N/A); Model Catalog: BI-IBDOC (Lot serial: N/A)
  • Product Description
    CALAPP;IBDOC CALPROTECTIN KIT;IBDOC CALPROTECTIN STARTER KIT
  • Manufacturer
    BUHLMANN DIAGNOSTICS CORP.

Manufacturer

BUHLMANN DIAGNOSTICS CORP.