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Vitek MS-CHCA Matrix and Vitek MS-DS Target Slides (2014-02-27)
- Starting date:
- February 27, 2014
- Posting date:
- April 4, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38663
Recalled products
- Vitek MS-CHCA Matrix
- Vitek MS-DS Target Slides
Reason
It has been confirmed that one of the positive QC strains, Enterococcus faecalis ATCC 19433, was not reproducible when tested on Vitek MS following culture on the Trypcase Soy Agar + 5% sheep blood (TSS) media. During development, this Enterococcus faecalis ATCC 19433 strain was tested after culture on the Colombia Agar + 5% sheep blood media. Therefore, the culture of this strain on the Trypcase Soy Agar + 5% sheep blood (TSS) media was never validated.
Affected products
A. Vitek MS-CHCA Matrix
Lot or serial number
Not applicable
Model or catalog number
- 411071
Companies
- Manufacturer
-
Biomerieux SA
chemin de l'Orme
Marcy l'Etoile
69280
FRANCE
B. Vitek MS-DS Target Slides
Lot or serial number
Not applicable
Model or catalog number
- 410893
Companies
- Manufacturer
-
Biomerieux SA
chemin de l'Orme
Marcy l'Etoile
69280
FRANCE