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Vitek MS
- Starting date:
- October 29, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15902
Recalled Products
- Vitek MS
- Vitek MS Ruo (with Saramis Database)
Reason
The currently available knowledgebase, Vitek MS Version 2.0, is known to have lower performance for the nine (9) mycobacteria species listed in the knowledgebase user manual supplement. Additionally, an internal study determined that in rare circumstances the current mycobacteria protocol might not completely inactivate multi drug resistant (MDR) M. tuberculosis when using 30/70 TFA/ETOH (trifluoroacetic/ethanol).
Affected products
A. Vitek MS
Lot or serial number
vérsion 2.0
Model or catalog number
410895
Companies
- Manufacturer
- Biomerieux SA
B. Vitek MS Ruo (with Saramis Database)
Lot or serial number
vérsion 2.0
Model or catalog number
410710
Companies
- Manufacturer
- Biomerieux SA