Health product recall

IBDoc Calprotectin Kit, Starter Kit and CalApp (2018-02-27)

Starting date:
February 27, 2018
Posting date:
April 3, 2018
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-66310

Affected products

  1. IBDoc Calprotectin Kit
  2. IBDoc Calprotectin Starter Kit
  3. CalApp

Reason

In isolated cases, a shifted test line of the IBDoc lateral flow test cassette falls outside of the read-out window of the CalApp interpretative software. The result is incorrectly interpreted as test line to control line ratio of 0 and a normal calprotectin value

Affected products

  1. 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


B. IBDoc Calprotectin Starter Kit

Lot or serial number

Not applicable

Model or catalog number

BI-IBDOC

Companies
Manufacturer

BÜHLMANN Laboratories AG

Baselstrasse 55

Schönenbuch

4124

SWITZERLAND


C. CalApp

Lot or serial number

Not applicable

Model or catalog number

CALAPP

Companies
Manufacturer

BÜHLMANN Laboratories AG

Baselstrasse 55

Schönenbuch

4124

SWITZERLAND


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