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VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST C (2015-03-30)
- Starting date:
- March 30, 2015
- Posting date:
- April 30, 2015
- 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-53165
Recalled Products
A. VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST C
Reason
Out of range low (OORL) flucytosine (FCT) QC results for Candida krusei ATCC 6258, the package insert QC strain, has been identified in association with the Vitec 2 AST-YS06 and AST-YS07 test kits.
Affected products
A. VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST C
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
412 610
414 967
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
Missouri
UNITED STATES