Becton Dickinson & Company recalls BD Vacutainer Urine Collection Cups, Cat. No. 364941

Recall date

August 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0491-2019

FDA classification

Class II

Brand / firm

Becton Dickinson & Company

Sold / distributed

Illinois

Why it was recalled

BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Vacutainer Urine Collection Cups, Cat. No. 364941