VITEK 2 Compact 30 System - Instrument (2017-03-02)
- Starting date:
- March 2, 2017
- Posting date:
- April 3, 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-66306
Affected products
VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
Reason
Several complaints were received for invalid calibration with low calibrator s1 while using VIDAS LH. Furthermore, tests performed internally confirmed a decrease of the strips signal overtime for the lot 1006041540. The defect was highlighted with complaints for invalid calibration, but concerns all tests performed (calibration, and patient's samples testing). The investigation concluded that this could have an impact on patient's results.
Affected products
VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
Lot or serial number
1006041540
Model or catalog number
30406
Companies
- Manufacturer
-
BioMérieux S.A
376 Chemin De L'orme
Marcy-l'etoile
69280
FRANCE