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Vitek 2 GN Card (2014-07-29)
- Starting date:
- July 29, 2014
- Posting date:
- August 15, 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-41039
Recalled products
- Vitek 2 GN Card
Reason
A potential non-conformity has been identified related to Vitek2 GN ID test kit: AGLU (Alpha Glucosidase) may have a false positive reaction with some isolates of E.coli for this lot of GN ID test kits, which may contributes to the misidentification of these isolates of E.coli as Serratia fonticola.
Affected products
A. Vitek 2 GN Card
Lot or serial number
- 241289140
Model or catalog number
- 21341
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
84894
Missouri
UNITED STATES