Elecsys Calcitonin (2019-10-07)
- Starting date:
- October 7, 2019
- Posting date:
- November 1, 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-71467
Last updated: 2019-11-01
Affected Products
Elecsys Calcitonin
Reason
The manufacturer performed drug interference testing and confirmed that an influence on recovery was found for itraconazole on Elecsys Calcitonin assays. The method sheets will be revised to include a disclaimer in the limitation-interference section.
Affected products
Elecsys Calcitonin
Lot or serial number
All lots.
Model or catalog number
6445853190
7027044190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY