Thursday July 19, 2018

FDA recalls BD Vacutainer K2 Edta

VOLUNTARY recall of BD Vacutainer K2 EDTA (K2E) blood collection tube is advised by the Food and Drug Administration (FDA) to concerned healthcare professionals, establishments, and the general public.

BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube measuring 13 x 75mm x 2.0ml has been found out to have been manufactured with a limited amount of K2 EDTA 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," read the official statement of FDA.

The blood collection tube is used for collecting venous blood. The specific product has a Catalog Code No. 367841, Lot No. of 6279849, and Registration No. of DVR- 3711. It is often sold in shelf pack of 100 tubes or in cases of 10 shelf packs. This product, which is locally distributed by Metro Drug Inc., had earlier been voluntarily recalled by Becton Dickinson and Company (BD).

FDA urged the distributors, retailers, hospitals, and healthcare professionals and users to discontinue further use, purchase, and selling of the product.