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
- IBDoc Calprotectin
- 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