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