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VIDAS - ESTRADIOL II ASSAY (2016-07-12)
- Starting date:
- July 12, 2016
- Posting date:
- August 5, 2016
- 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-59696
Affected products
A. VIDAS - ESTRADIOL II ASSAY
Reason
The drug fulvestrant cross react with antibodies used in immunoassays on the market. This is due to the fact that the fulvestrant molecule has a similar chemical structure to estradiol which leads to an overestimation of estradiol level.
Affected products
A. VIDAS - ESTRADIOL II ASSAY
Lot or serial number
1004343690
1004403350
1004666000
Model or catalog number
30431
Companies
- Manufacturer
-
Biomerieux Sa
Chemin De L'orme
Marcy-l'etoile
69280
FRANCE