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VITEK 2 SYSTEM(2015-08-20)
- Starting date:
- August 20, 2015
- Posting date:
- October 8, 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-55272
Affected Products
- VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
- VITEK 2 COMPACT 60 SYSTEM - INSTRUMENT
- VITEK 2 SYSTEM - VITEK 2 INSTRUMENT
Reason
Vitek 2 Systems bioART rule #5094 is predefined in response to a United States FDA limitation for bensylpenicillin and Streptococcus pneumoniae due to inadequate numbers of isolates at minimum inhibitory concentration (MIC) more than (or equal to) 8 ug/ml during impact AST-ST (antimicrobial susceptibility testing-Streptococca) cards. No AST-GP (gram positive) or AST-P cards are impacted. Note: bioART rule #5094 is enabled by default in the Vitek 2 7.01 Software.
Affected products
-
VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
Lot or serial number
- 27225
Model or catalog number
Software version 7.01
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
Missouri
UNITED STATES
B. VITEK 2 COMPACT 60 SYSTEM - INSTRUMENT
Lot or serial number
27560
Model or catalog number
Software version 7.01
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
Missouri
UNITED STATES
C. VITEK 2 SYSTEM - VITEK 2 INSTRUMENT
Lot or serial number
27225
Model or catalog number
Software version 7.01
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
Missouri
UNITED STATES