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Vitek 2 Gp Id
- Starting date:
- August 9, 2017
- Posting date:
- September 11, 2017
- 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-64472
Reason
Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC 700327 in association with Vitek 2 GP ID, causing failure of the quality control testing. The expected O129R reaction for ATCC 700327 strain is positive.
Affected products
Vitek 2 Gp Id
Lot or serial number
- 2420240403
- 2420303403
Model or catalog number
21342
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham
27712
North Carolina
UNITED STATES