Health product recall

VIDAS SYSTEM - Analyzer Class 3 and miniVIDAS Analyzer (2018-01-10)

Starting date:
January 10, 2018
Posting date:
February 22, 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-66024

Affected products

A. VIDAS SYSTEM - ANALYZER CLASS 3 (w/ Class 3 Reagents)
B. VIDAS SYSTEM - ANALYZER CLASS 3 (w/ Class 2 Reagents)
C. MINIVIDAS ANALYZER

Reason

An anomaly with the aspiration or dispensing steps performed by the pump (particularly due to pump clogging) may impact the volume of patient sample pipetted or the other solutions transferred into the strip wells. As a volume decrease could induce an impact on the biological test result, the Quality Control Vidas (QCV) test has been designed to detect pump issues and alert the user before a biological test result is affected. QCV frequency and threshold alert have been defined to enable the system to detect progressive clogging.

Affected products

A. VIDAS SYSTEM - ANALYZER CLASS 3 (w/ Class 3 Reagents)

Lot or serial number

All lots

Model or catalog number

W2205

Companies
Manufacturer
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE

B. VIDAS SYSTEM - ANALYZER CLASS 3 (w/ Class 2 Reagents)

Lot or serial number

All lots

Model or catalog number

410416
99733
99735
99737
W2205

Companies
Manufacturer
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE

C. MINIVIDAS ANALYZER

Lot or serial number

All lots

Model or catalog number

REF. 410416

Companies
Manufacturer
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE