Health product recall

IBDoc Calprotectin, IBDoc Calprotectin Kit (2019-03-19)

Starting date:
March 19, 2019
Posting date:
April 5, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69492



Last updated: 2019-04-05

Affected Products

  1. IBDoc Calprotectin
  2. IBDoc Calprotectin Kit

Reason

The IBDoc has an error in the design of the result upload process. Whenever a group of results is uploaded to the IBDoc Portal and one of the results in that group was already received on a separate occasion (duplicate result) then the entire group of results does not get processed further, even though the IBDoc Portal returns a success status to CalApp.

Affected products

A. IBDoc Calprotectin

Lot or serial number

Not applicable.

Model or catalog number
  • B-IBDOC
Companies
Manufacturer

BÜHLMANN Laboratories AG

Baselstrasse 55

Schönenbuch

4124

SWITZERLAND


B. IBDoc Calprotectin Kit

Lot or serial number

Not applicable.

Model or catalog number
  • LF-IBDOC8
Companies
Manufacturer

BÜHLMANN Laboratories AG

Baselstrasse 55

Schönenbuch

4124

SWITZERLAND