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Health product recall

INTERCEPT ORAL SPECIMEN COLLECTION KIT (2016-04-13)

Starting date:
April 13, 2016
Posting date:
April 29, 2016
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-58132

Affected Products

INTERCEPT ORAL SPECIMEN COLLECTION KIT

Reason

Associated product technical bulletin MP-12-077 meets the Canadian Medical Devices Regulations definition for recall.

Affected products

INTERCEPT ORAL SPECIMEN COLLECTION KIT

Lot or serial number

All lots.

Model or catalog number

503-0509
503-0510
503-0511
503-0512

Companies
Manufacturer
Orasure Technologies, Inc.
220 EAST FIRST STREET
BETHLEHEM
Pennsylvania
UNITED STATES