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.
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company has recalled BD Vacutainer K2 EDTA 3.6mg Blood Collection Tubes (catalog number 367841, lot number 6279849) due to a manufacturing defect. A limited portion of the affected lot contains less than the required amount of K2EDTA additive, an anticoagulant used in blood collection tubes. Approximately 8.49 million tubes were distributed nationwide.
The defect may cause blood test results to be inaccurate, potentially leading to the need to recollect blood samples and delaying patient treatment. Serious complications could result, including failure to detect thrombocytosis (abnormally high platelet counts) or inappropriate postponement of surgery. The source does not specify what remedy is available to affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Nationwide Distribution Quantity: 8,494,000 Lot/code info: Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.