CgA-ELISA and ALDO-RIACT (2018-11-22)
- Starting date:
- November 22, 2018
- Posting date:
- December 10, 2018
- 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-68560
Affected products
A. CgA-ELISA
B. ALDO-RIACT
Reason
Exogen biotin found in various food supplements and medical treatments may interfere with immunoassays for which biotin is part of the functional principle, when samples with high biotin concentrations are analyzed.
Affected products
A. CgA-ELISA
Lot or serial number
All lots.
Model or catalog number
CGA-ELISA
Companies
- Manufacturer
-
Cisbio Bioassays
Parc Marcel Boiteux, BP 84175
Codolet
30200
FRANCE
B. ALDO-RIACT
Lot or serial number
All lots.
Model or catalog number
ALDO-RIACT
Companies
- Manufacturer
-
Cisbio Bioassays
Parc Marcel Boiteux, BP 84175
Codolet
30200
FRANCE