FDA-Device2018-03-21Class II
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
Becton Dickinson & Company
Hazard
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.
Sold states
Nationwide Distribution
Affected count
8,494,000
Manufactured in
1 Becton Dr, Franklin Lakes, NJ, United States
Products
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0968-2018Don't want to check this manually?
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