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
- IBDoc Calprotectin Kit
- IBDoc Calprotectin Starter Kit
- 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
-
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
30>