proBNP II Stat Calset, proBNP II Calset and Calset proBNP II (2019-08-22)
- Starting date:
- August 22, 2019
- Posting date:
- September 20, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-71011
Last updated: 2019-09-20
Affected Products
- proBNP II Stat Calset
- proBNP II Calset
- Calset proBNP II
Reason
Following the information provided by the manufacturer on internal investigation of customer complaints on different formats of Elecsys proBNP II CalSets (cat # 04842472190, 05390117190 and 07360886190 for all lots), a change in storage conditions will be implemented in all methods sheets.
Affected products
A. proBNP II Stat Calset
Lot or serial number
All lots.
Model or catalog number
- 05390117190
- 07360886190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. proBNP II Calset
Lot or serial number
All lots.
Model or catalog number
04842472190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. Calset proBNP II
Lot or serial number
All lots.
Model or catalog number
07360886190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY