This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Elecsys proBNP II and proBNP II Stat (2017-03-13)
- Starting date:
- March 13, 2017
- Posting date:
- March 31, 2017
- 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-62860
Affected Products
- Elecsys proBNP II
- Elecsys proBNP II Stat
Reason
Patients may show discrepant results when tested with the assay kit (value < LOD or values < LDL) due to a NT-proBNP genetic variant. As a consequence, the manufacturer will update the method sheets accordingly in the limitations-interference section.
Affected products
A. Elecsys proBNP II
Lot or serial number
All lots
Model or catalog number
4842464190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Elecsys proBNP II Stat
Lot or serial number
All lots
Model or catalog number
5390109190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY