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VITEK 2 GP ID (2017-10-16)
- Starting date:
- October 16, 2017
- Posting date:
- October 30, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-64994
Affected products
VITEK 2 GP ID
Reason
An internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC 700327 in association with three (3) VITEK 2 GP ID lots causing failure of the quality control (QC) testing for the VITEK 2 GP ID card.
Affected products
VITEK 2 GP ID
Lot or serial number
2420348103
Model or catalog number
21342
Companies
- Manufacturer
-
Biomerieux Inc.
595 Anglum Road
Hazelwood
63042
Missouri
UNITED STATES