—#161224

Product

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.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: BK050036
Affected lot / code info: Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

In August of 2017 All US direct consignees were contacted via e-mail and/or UPS mail. An Urgent Product Removal Recall letter was issued, identifying the affected device and the reason for the recall. It also requested customers to review their inventory and quarantine any affected devices, which will be returned to the firm for replacement. The Customer Recall Response Form should be completed and returned regardless of whether there is any affected devices on hand. For questions or concerns please contact Customer Service at 1-855-215-4992.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2017-08-29
Terminated: 2019-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161224. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.