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VITEK 2 Compact 30 System - Instrument, VITEK 2 Compact 60 System - Instrument, VITEK 2 System - VITEK 2 XL Instrument (2015-01-07)
- Starting date:
- January 7, 2015
- Posting date:
- February 20, 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-43789
Recalled products
- VITEK 2 Compact 30 System - Instrument
- VITEK 2 Compact 60 System - Instrument
- VITEK 2 System - VITEK 2 XL Instrument
Reason
A discrepant inoculum density range has been identified for the Neisseria Haemophilus (NH) Identification (ID) test card in the VITEK 2 7.01 product information document (ref 514740-1xx1, where xx indicates the language translation code).
Affected products
A. VITEK 2 Compact 30 System - Instrument
Lot or serial number
Not applicable
Model or catalog number
- 27530
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
Missouri
UNITED STATES
B. VITEK 2 Compact 60 System - Instrument
Lot or serial number
Not applicable
Model or catalog number
- 27560
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
Missouri
UNITED STATES
C. VITEK 2 System - VITEK 2 XL Instrument
Lot or serial number
Not applicable
Model or catalog number
- 27225
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
Missouri
UNITED STATES