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Health product recall

DENGUE NS1 AG STRIP (2015-01-06)

Starting date:
January 6, 2016
Posting date:
February 1, 2016
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-56888

Affected Products

DENGUE NS1 AG STRIP

Reason

An unexpected amount of negative results from supposedly positive patient samples have been received. A sudden and unusual degradation of the sensitivity of these lots has been observed further to a punctual and isolated event.

Affected products

DENGUE NS1 AG STRIP

Lot or serial number
  • 5F0130
Model or catalog number
  • 70700
Companies
Manufacturer
Bio-Rad
3 BOULEVARD RAYMOND POINCARE
MARNES-LA-COQUETTE
FRANCE