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Health product recall

BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes (2017-08-28)

Starting date:
August 28, 2017
Posting date:
September 26, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-64564

Affected Products

BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes

Reason

BD has confirmed that a limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.

Affected products

BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes

Lot or serial number

6279849

Model or catalog number

367841

Companies
Manufacturer

Becton Dickinson and Company

1 Becton Drive

Franklin Lakes

07417

New Jersey

UNITED STATES