This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
AccuMAb Plus Bordetella pertussis /parapertussis DFA (2014-03-01)
- Starting date:
- March 1, 2014
- Posting date:
- May 21, 2015
- 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-53395
Recalled Products
A. AccuMAb Plus Bordetella pertussis /parapertussis DFA
Reason
Declining fluorescence for Bordetella pertussis. False negative results for Bordetella parapertussis. Bordetella parapertussis falsely identified as Bordetella pertussis. When reagent is used neat (undiluted) it may cause the bacteria smear to detach from the glass microscope slide, resulting in no visible fluorescence.
Affected products
A. AccuMAb Plus Bordetella pertussis /parapertussis DFA
Lot or serial number
- 01183
- 10253
Model or catalog number
4020-BP002-01
Companies
- Manufacturer
-
Delta Biotech Inc.
1600 Derwent Way, Suite 3
Delta
V3M 6M5
British Columbia
CANADA