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Health product recall

INTERCEPT I2 ORAL FLUID (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-58136

Affected Products

INTERCEPT I2 ORAL FLUID

Reason

Associated product technical bulletin OS-14-001 meets the Canadian Medical Devices Regulations definition for recall.

Affected products

INTERCEPT I2 ORAL FLUID

Lot or serial number

All lots.

Model or catalog number

1001-0362
1001-0363

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