Health product recall

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