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ROCHE DIAGNOSTICS ESTRADIOL (2016-03-08)
- Starting date:
- March 8, 2016
- Posting date:
- March 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-57682
Affected products
- ESTRADIOL II
- ESTRADIOL III
Reason
The reason for the recall is related to a situation where the manufacturer has identified during an internal investigation, that the substance fulvestrant may lead to falsely elevated results in the Elecsys Estradiol II and Elecsys Estradiol III assays.
Affected products
A. ESTRADIOL II
Lot or serial number
All lots.
Model or catalog number
3000079190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. ESTRADIOL III
Lot or serial number
All lots.
Model or catalog number
6656021190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY